This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Avastin +/- Erlotinib Consolidation Chemotherapy After Carboplatin, Paclitaxel, and Avastin (CTA) Induction Therapy for Advanced Ovarian, Fallopian Tube, Primary Peritoneal Cancer & Papillary Serous or Clear Cell Mullerian Tumors (NCT00520013), a randomized phase 2 study. The primary outcome is Consolidation Progression-Free Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00520013 |
| Phase | Phase 2 |
| Condition | Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 60 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Dana-Farber Cancer Institute |
| Results posted | Yes |
2. Clinical Question
Population
Patients with newly diagnosed advanced ovarian cancer, fallopian tube cancer, primary peritoneal cancer, or papillary serous or clear cell Mullerian tumors who reached the consolidation-treatment analysis population. The registry record says the primary analysis dataset comprised patients randomized to consolidation treatment. The detailed eligibility criteria and the number who did not reach consolidation are not reported in the registry record.
Intervention
Consolidation with bevacizumab and erlotinib after induction with carboplatin, paclitaxel, and bevacizumab. The registry describes induction as six cycles, with bevacizumab starting with cycle 2. Consolidation could continue for up to 1 year.
Comparator
Consolidation with bevacizumab alone after the same carboplatin, paclitaxel, and bevacizumab induction. The trial was randomized and used parallel treatment groups. The registry does not report the randomization procedure or allocation ratio.
Primary question
Among patients randomized to consolidation, how did the time from the first day of consolidation to documented disease progression or disease-specific death compare between bevacizumab alone and bevacizumab plus erlotinib? The registry reports a median for each arm, but a comparative hazard ratio and an estimable two-arm test are not reported in the registry record.
The trial was designed to examine first-line consolidation after induction, rather than to compare the induction regimen with another induction treatment. Both groups had received carboplatin, paclitaxel, and bevacizumab before the consolidation comparison. Consequently, the reported arm results address outcomes among patients who entered consolidation, not outcomes for every patient enrolled at the start of the study.
The registry lists enrollment of 60 and reports primary-outcome analysis group sizes of 23 and 25. The record does not explain the path from enrollment to the consolidation analysis population. Reasons for non-entry, exclusion, or other differences between these counts are not reported in the registry record.
3. Trial Design
This was a randomized, open-label, parallel-group phase II trial sponsored by Dana-Farber Cancer Institute. The registry lists a start date of 2007-08, primary completion of 2010-10, and status as completed. Masking is listed as none, so participants and study personnel were not masked to assigned consolidation treatment according to the registry record.
All groups began with induction therapy described as carboplatin, paclitaxel, and bevacizumab. The listed induction schedule was carboplatin IV AUC 5, paclitaxel IV 175 mg/m2, and bevacizumab IV 15 mg/kg on day 1, with a 21 day cycle for six cycles. Bevacizumab began with cycle 2. Consolidation then consisted of bevacizumab alone or bevacizumab with erlotinib. The registry describes consolidation treatment for up to 1 year. Its arm descriptions are truncated after a statement about patients with radiographic progression after induction, so the complete advancement criteria are not reported in the registry record.
For the primary outcome, the posted analysis includes 23 patients in the bevacizumab-alone arm and 25 in the bevacizumab-plus-erlotinib arm. The posted median progression-free survival is 13.3 months in the bevacizumab-alone arm, with a lower 95% confidence limit of 10.1 months; it is 18.9 months in the combination arm, with a lower limit of 15.4 months. An upper confidence limit is not reported for either arm.
The trial is randomized, but details of sequence generation, allocation concealment, stratification, and the intended allocation ratio are not reported in the registry record. The record also does not report a protocol-level sample-size justification. Its enrollment figure should therefore not be interpreted as evidence of a particular power target or of the number included in the primary analysis.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Overall Study
| Stage | Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab | Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib | Carboplatin/Paclitaxel/Bevacizumab |
|---|---|---|---|
| STARTED | 23 | 25 | 11 |
| Treated | 23 | 25 | 11 |
| COMPLETED | 11 | 10 | 0 |
| NOT COMPLETED | 12 | 15 | 11 |
Reasons for not completing this period:
| Reason | Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab | Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib | Carboplatin/Paclitaxel/Bevacizumab |
|---|---|---|---|
| Withdrawal by Subject | 0 | 0 | 1 |
| Adverse Event | 2 | 10 | 7 |
| Progressive Disease | 7 | 3 | 0 |
| Clinical Progression | 3 | 1 | 0 |
| Death | 0 | 1 | 0 |
| Physician Decision | 0 | 0 | 3 |
Analysis population for the primary outcome, as defined in the registry: The analysis dataset is comprised of patients randomized to consolidation treatment.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: The analysis dataset is comprised of treated patients.
| Characteristic | Unit | Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab | Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib | Carboplatin/Paclitaxel/Bevacizumab | Total |
|---|---|---|---|---|---|
| Participants analysed | 23 | 25 | 11 | 59 | |
| Age, Continuous | years | 58 (48 to 63) | 56 (49 to 61) | 54 (51 to 59) | 57 (49 to 61) |
| Sex: Female, Male: Female | Participants | 23 | 25 | 11 | 59 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 23 | 25 | 11 | 59 |
| Cancer Type: Primary peritoneal | participants | 4 | 1 | 1 | 6 |
| Cancer Type: Fallopian tube | participants | 5 | 4 | 1 | 10 |
| Cancer Type: Epithelial ovarian | participants | 10 | 17 | 8 | 35 |
| Cancer Type: Uterine papillary serous | participants | 2 | 1 | 1 | 4 |
| Cancer Type: Other (mixed, carcinosarcoma) | participants | 2 | 2 | 0 | 4 |
6. Primary Endpoint
The registry lists the primary outcome as Consolidation Progression-Free Survival, measured over Assessments occurred every cycle (serologic) and every 3 cycles (radiologic) on consolidation treatment. Pts were allowed on consolidation therapy for up to 1 year and upon treatment discontinuation were followed for another year..
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint is consolidation progression-free survival, reported as a median time in months. It measures the time from the first day of consolidation therapy until documented disease progression or disease-specific death. This timing focuses the endpoint on the period after patients begin their assigned consolidation treatment, rather than on the entire interval beginning with induction.
Progression could be identified by radiographic or serologic criteria. Under RECIST 1.1, radiographic progression included at least a 20% increase in the sum of target-lesion diameters relative to the smallest sum since consolidation began, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. Under Rustin criteria, serologic progression was a rise in CA125 since consolidation began, or a previously normal CA125 rising to at least 2xULN, with either event documented on two occasions.
Patients without an event were censored at their last disease evaluation. Censoring allows follow-up information from patients who have not had a recorded event to contribute up to the point their status was last assessed. It also means that the median and its precision depend on event occurrence and follow-up, not simply on the number assigned to each arm.
Progression-free survival is used to describe how long patients remain alive without documented progression under the endpoint definition. It is not the same as overall survival, and the posted median alone does not describe the probability of remaining progression-free at every point in follow-up.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports median consolidation progression-free survival of 13.3 months for bevacizumab alone and 18.9 months for bevacizumab plus erlotinib. The corresponding lower limits of the reported 95% confidence intervals are 10.1 months and 15.4 months. Upper confidence limits are not reported. These are separate arm-level estimates; they do not by themselves quantify the uncertainty in the contrast between randomized groups.
A median is the estimated time by which half of the analyzed group has experienced the endpoint, under the Kaplan-Meier method and the endpoint’s censoring rules. It is not a mean follow-up time, nor does it say that every participant experienced progression or disease-specific death at that time. Because the confidence intervals are incomplete in the registry record, the precision of each estimate cannot be fully characterized from the posted limits.
The registry does not report a sponsor-estimated hazard ratio or a p-value for the primary comparison. It also indicates that values are missing or not estimable for a two-arm comparison of this median-time endpoint. Accordingly, the arm medians should not be treated as a formal estimate of the treatment contrast, and the posted values do not establish whether a between-arm difference is statistically distinguishable from chance. The sponsor’s comparative analysis is not available in the registry record.
The two groups were randomized, but the outcome population is described as patients randomized to consolidation. The posted group sizes for this analysis are 23 and 25, while registry enrollment is 60. The record does not explain who was excluded from or did not enter the consolidation analysis, so these arm estimates should be read as applying to the reported analysis population. They do not automatically describe all enrolled patients or all patients who might begin induction in another setting.
The outcome definition combines radiographic and CA125-based progression criteria, together with disease-specific death. Assessments occurred every cycle for serologic evaluation and every 3 cycles for radiologic evaluation during consolidation. The timing and type of assessments can affect when progression is detected and recorded. The registry does not report further details about adjudication, assessment completeness, or how discordant assessments were resolved.
These results describe the posted trial data and their limits. They do not establish that adding erlotinib causes longer progression-free survival, nor do the available results establish the absence of an effect. A comparative estimate with its uncertainty and the analysis details would be needed to characterize the randomized contrast more directly.
9. Statistical Methods Explained
What does a Kaplan-Meier median represent?
The registry says consolidation progression-free survival was analyzed using the Kaplan-Meier method. In general, this method estimates the pattern of event-free survival over time while allowing some participants to have incomplete follow-up. A participant without a recorded endpoint is censored at the last disease evaluation, as specified in this trial. Censoring retains information up to that evaluation rather than treating the participant as if an event had occurred then.
The Kaplan-Meier median is the time at which the estimated event-free proportion reaches the median point, when that point can be estimated. It is a summary of the estimated time-to-event curve. It does not show the curve’s full shape, and equal or different medians alone cannot capture all possible differences in event timing. The posted results give the median for each arm but do not provide the curve values or an upper confidence limit for either median.
What does a confidence interval convey?
In general, a confidence interval expresses uncertainty around an estimate under the statistical method used. A wider interval indicates less precision than a narrower interval, all else being equal. The record labels the dispersion for the endpoint as a 95% confidence interval and reports only its lower limit for each arm: 10.1 months for bevacizumab alone and 15.4 months for bevacizumab plus erlotinib. Since the upper limits are not reported, the intervals cannot be fully assessed from the registry record.
The interval for an arm-specific median is not the same as a confidence interval for the difference between arms or for a hazard ratio. A comparison requires an estimate and uncertainty calculated for the contrast itself. Those comparative statistics are not reported in the registry record, and the record notes that the two-arm comparison for this median-time endpoint is missing or not estimable.
Why do time-to-event comparisons often use a hazard ratio?
In general, a hazard ratio compares the instantaneous event rates between groups over follow-up, conditional on remaining event-free up to each time. It uses information across the observed follow-up period, whereas a median focuses on one point of each estimated curve. Interpreting a hazard ratio also depends on the analysis and assumptions, including whether the relative event rates are reasonably represented by a single summary over time.
The registry states that only sponsor-reported hazard ratios are used for time-to-event results. No sponsor-reported hazard ratio or associated inferential result is included in this record. A hazard ratio cannot be recovered from the arm medians alone, so no comparative estimate should be inferred from them.
How should the event definition be understood?
The endpoint counts documented disease progression or disease-specific death from the first day of consolidation. Radiographic progression used RECIST 1.1 criteria, including at least a 20% increase in the target-lesion diameter sum from the smallest sum since consolidation began, new lesions, or unequivocal progression of existing non-target lesions. Serologic progression used the stated CA125 rules under Rustin criteria, with either qualifying event documented on two occasions.
In general, combining assessment types can capture events that may be detected through different monitoring approaches. The registry says assessments occurred every cycle for serologic evaluation and every 3 cycles for radiologic evaluation while on consolidation. Thus, the endpoint depends on scheduled assessment and documentation, as well as on the underlying disease course. More detail about assessment review, missing assessments, or the handling of conflicting results is not reported in the registry record.
What do the planning illustrations mean?
In general, a sample-size planning illustration asks how many participants or events a hypothetical future study might need under stated assumptions. The registry’s stated assumptions for these illustrations are a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. For time-to-event illustrations, the stated quantity is the total number of events, using the Schoenfeld approach. These are planning quantities, not observed trial outcomes.
Such illustrations are not observed power and do not establish the design rationale used for this trial. The registry does not report a trial-specific sample-size justification, and no trial design assumptions beyond those stated for the planning illustrations should be inferred. The posted arm medians are not themselves evidence that a particular planning target was achieved.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists three outcome measures and one posted secondary outcome, consolidation objective response rate. It does not report a multiplicity adjustment, a testing hierarchy, or a plan for controlling the chance of false-positive findings across outcomes. Whether a prespecified multiplicity strategy was used is not reported in the registry record. Without those details, results across multiple endpoints should not be treated as if they necessarily arose from a single isolated test.
The primary outcome analysis population is described as patients randomized to consolidation. The record does not give a complete participant flow from enrollment through induction, consolidation randomization, and outcome analysis. It also does not explain the difference between enrollment of 60 and the arm-specific analysis group sizes of 23 and 25. Reasons for missing outcomes, withdrawals, exclusions, or non-entry to consolidation are not reported in the registry record.
The endpoint definition specifies censoring event-free patients at their last disease evaluation, but additional missing-data methods are not reported. The record does not describe sensitivity analyses, imputation, or how missing radiographic or serologic evaluations were handled. Those omissions matter because the timing and completeness of follow-up inform a Kaplan-Meier analysis.
The registry reports no analyses for the primary outcome comparison and does not provide a comparative hazard ratio or p-value. It also does not report an intention-to-treat analysis population definition beyond the statement that the analysis dataset comprised patients randomized to consolidation. The exact analysis plan, including any interim analyses or prespecified subgroup analyses, is not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab | 7 | 23 | 30.4% |
| Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib | 18 | 25 | 72.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab | 23 of 23 |
| Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib | 25 of 25 |
Most frequent serious adverse event terms
| Event term | Organ system | Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab | Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib |
|---|---|---|---|
| Hypertension | Vascular disorders | 6 of 23 | 4 of 25 |
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | 0 of 23 | 5 of 25 |
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | 0 of 23 | 3 of 25 |
| Fatigue | General disorders | 1 of 23 | 1 of 25 |
| Hemoglobin | Blood and lymphatic system disorders | 0 of 23 | 1 of 25 |
| Colitis | Gastrointestinal disorders | 0 of 23 | 1 of 25 |
| Enteritis | Gastrointestinal disorders | 0 of 23 | 1 of 25 |
| Infection-other | Infections and infestations | 0 of 23 | 1 of 25 |
| Wound - non-infectious | Injury, poisoning and procedural complications | 0 of 23 | 1 of 25 |
| Hyponatremia | Metabolism and nutrition disorders | 0 of 23 | 1 of 25 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab | Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib |
|---|---|---|---|
| Fatigue | General disorders | 18 of 23 | 21 of 25 |
| Neuropathy-sensory | Nervous system disorders | 14 of 23 | 12 of 25 |
| Alopecia | Skin and subcutaneous tissue disorders | 12 of 23 | 11 of 25 |
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | 5 of 23 | 18 of 25 |
| Nose, hemorrhage | Respiratory, thoracic and mediastinal disorders | 13 of 23 | 7 of 25 |
| Joint, pain | Musculoskeletal and connective tissue disorders | 12 of 23 | 7 of 25 |
| Hypertension | Vascular disorders | 9 of 23 | 9 of 25 |
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | 1 of 23 | 16 of 25 |
| Hemoglobin | Blood and lymphatic system disorders | 8 of 23 | 8 of 25 |
| Hypomagnesemia | Metabolism and nutrition disorders | 7 of 23 | 8 of 25 |
Serious events with the highest arm-level rate: hypertension (26.1%), diarrhea w/o prior colostomy (20.0%), rash: acne/acneiform (12.0%), fatigue (4.3%), joint, pain (4.3%).
The registry lists serious adverse events in both consolidation groups. In the bevacizumab-alone group, 7 participants were affected among 23 at risk; in the bevacizumab-plus-erlotinib group, 18 were affected among 25 at risk. These are group-specific counts, not a randomized estimate of the effect of treatment on serious adverse events. The record does not report deaths in either group.
For other adverse events, the registry reports 23 affected among 23 at risk in the bevacizumab-alone group and 25 affected among 25 at risk in the combination group. These counts are reported separately from the serious-event counts. The registry’s leading serious-event terms include hypertension (26.1%), diarrhea without prior colostomy (20.0%), acne or acneiform rash (12.0%), fatigue (4.3%), joint pain (4.3%), and muscle pain (4.3%). The terms may overlap within participants, so they should not be added together.
In general, adverse-event counts depend on the defined reporting period, event definitions, and the number observed and assessed. The registry does not report enough detail to establish a comparative safety analysis, including event severity breakdowns, exposure-adjusted rates, or a statistical test. These figures describe reported events; they do not, on their own, establish that an event was caused by a study drug.
12. What the Result Does, and Does Not, Mean
The posted primary results show arm-specific medians for progression-free survival during consolidation: 13.3 months with bevacizumab alone and 18.9 months with bevacizumab plus erlotinib. The registry reports lower 95% confidence limits of 10.1 months and 15.4 months, respectively, but does not report the upper limits. The values describe the analysis populations and endpoint definitions recorded in the registry.
They do not provide a complete statistical comparison. The record does not contain a sponsor-reported hazard ratio, a p-value, or an estimable two-arm comparison for the median-time endpoint. It is therefore not possible to characterize the precision of a treatment contrast from these results. Comparing the numerical medians informally would not replace an analysis of the randomized groups with an appropriate comparative estimate and uncertainty.
The analysis concerns patients randomized to consolidation after induction, rather than all patients enrolled at the start of the trial. The record does not explain how many enrolled patients reached consolidation or why the primary analysis group sizes differ from enrollment. The findings therefore should not be generalized automatically to patients who did not enter the consolidation comparison.
The primary endpoint is progression-free survival, not overall survival. It uses documented radiographic or CA125-based progression criteria, or disease-specific death, and censors event-free patients at their last disease evaluation. Interpretation depends on those definitions and the timing and completeness of assessment. The registry does not report the full confidence intervals, detailed follow-up distribution, or comparative analysis needed to resolve these uncertainties.
In general, a randomized design is intended to support comparison of assigned groups, but the design label alone does not supply the missing effect estimate or analysis details. The posted information can describe the reported outcomes and their limitations; it cannot establish that adding erlotinib improves outcomes, has no effect, or produces a particular magnitude of effect.
13. Why This Trial Matters Statistically
This trial raises a useful statistical distinction between an arm-level outcome summary and a treatment comparison. A median progression-free survival value summarizes one point on an estimated time-to-event curve. A comparative question, however, concerns how the groups differ across follow-up and how uncertain that contrast is. The registry gives arm medians but no sponsor-reported comparative hazard ratio or estimable two-arm test for this endpoint.
The trial also illustrates why the analysis population matters. Induction preceded randomization to consolidation, and the primary analysis dataset is described as patients randomized to consolidation. Enrollment is 60, while the primary outcome group sizes are 23 and 25. Without a participant-flow account, readers cannot determine from the registry record how those populations relate or how the reported results apply to patients who did not enter consolidation.
Endpoint construction is another important feature. Progression could be determined through radiographic criteria or CA125 criteria, and event-free participants were censored at their last disease evaluation. The assessment schedule and criteria define what counts as an event and when it is recorded. Those details are central to interpreting a time-to-event result, not merely administrative descriptions.
Finally, a phase II randomized study can report informative descriptive results even when the registry does not include a complete comparative analysis. That distinction helps prevent arm medians, incomplete confidence intervals, or adverse-event counts from being mistaken for a definitive estimate of treatment effect. In this record, the limits of the posted analysis are as important to interpretation as the reported medians.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation is that the registry reports medians and lower confidence limits but not upper confidence limits for either arm. It also does not report a comparative hazard ratio, a p-value, or an estimable two-arm comparison for the primary endpoint. The strength and precision of a between-arm conclusion therefore cannot be assessed from the posted primary results.
The record does not provide a complete account of participant flow. It lists enrollment of 60 and primary-outcome analysis group sizes of 23 and 25, but does not report why participants were not included in the consolidation analysis or whether they experienced progression before consolidation. The analysis population is described as patients randomized to consolidation, so the results should not be assumed to represent all enrolled patients.
The intervention descriptions are truncated after mentioning radiographic progression after induction. Full rules for moving from induction to consolidation are not reported in the registry record. Details of randomization, allocation concealment, stratification, trial-specific sample-size justification, interim analyses, and the statistical analysis plan are also not reported.
The registry specifies event definitions and assessment timing, but does not report the completeness of assessments, the amount of follow-up, sensitivity analyses, or methods for handling missing assessments beyond censoring at the last disease evaluation. It also does not report a multiplicity strategy for the listed outcomes. These omissions limit assessment of potential bias, precision, and the interpretation of any findings across outcomes.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Avastin +/- Erlotinib Consolidation Chemotherapy After Carboplatin, Paclitaxel, and Avastin (CTA) Induction Therapy for Advanced Ovarian, Fallopian Tube, Primary Peritoneal Cancer & Papillary Serous or Clear Cell Mullerian Tumors — NCT00520013.
- Registry record last updated 2018-07-27; status last verified 2018-07.
- Results first posted 2015-07-03.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT00520013 is a completed randomized, open-label phase II trial of consolidation bevacizumab alone or bevacizumab plus erlotinib after carboplatin, paclitaxel, and bevacizumab induction for newly diagnosed advanced ovarian and related Mullerian cancers. The registry lists enrollment of 60 and primary completion in 2010-10.
The primary outcome was consolidation progression-free survival, measured from the first day of consolidation to documented progression or disease-specific death. Reported medians were 13.3 months with bevacizumab alone and 18.9 months with bevacizumab plus erlotinib. Lower 95% confidence limits were 10.1 months and 15.4 months; upper limits are not reported.
A comparative hazard ratio, p-value, and estimable two-arm primary comparison are not reported in the registry record. The analysis population, participant flow, and several aspects of the statistical plan are incompletely described.