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 Clinical Trial of Docetaxel in Combination With Gemcitabine in Platinum-Resistant Ovarian Cancer and Primary Peritoneal Carcinoma (NCT00183794), a non-randomized phase 2 study. The primary outcome is Tumor Response Type: CR, PR, SD or PD.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00183794 |
| Phase | Phase 2 |
| Condition | Ovarian Carcinoma, Peritoneal Neoplasms |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 20 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Southern California |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned patients with advanced ovarian cancer that had reappeared after conventional treatment, and included ovarian carcinoma and peritoneal neoplasms. For the primary tumor-response analysis, the registry specifies participants with evaluable or measurable tumor who completed 2 courses of treatment. It does not report how many participants met that analysis-population definition.
Intervention
The intervention was docetaxel combined with gemcitabine. The regimen description specifies docetaxel 75mg/m2 intravenously on day 1, followed by gemcitabine 800 mg/m2 intravenously on days 1 and 8; cycles were to repeat every 3 weeks.
Comparator
There was no comparator group. The study is identified as non-randomized and single-group, so the registry record does not offer a concurrent control for comparing outcomes or adverse events.
Primary question
The primary outcome was tumor response categorized as complete response, partial response, stable disease, or progressive disease. The stated assessment time was 6 months after enrollment of the last participant. Responders were defined as participants with complete or partial response. The registry record does not report the response counts or a treatment-effect estimate, so the clinical question cannot be answered from the posted primary outcome information alone.
3. Trial Design
This was a phase II, non-randomized, unmasked, single-group trial sponsored by the University of Southern California. The registry lists enrollment of 20 and a completed status. The recorded study start was 2002-11, and primary completion was 2009-05. These registry dates describe the study record; they do not supply details about recruitment pace or the timing of individual participants’ assessments.
All participants were assigned to the combination regimen described in the record. Because there was no randomized allocation and no separate control group, the design is not a like-for-like treatment comparison. Any observed outcome in this study would describe participants receiving the regimen, but it would not by itself establish what would have happened to comparable participants receiving another treatment or no study treatment.
The primary outcome was tumor response type, assessed using RECIST v1.0 criteria. The record says disease assessment was performed every 2 cycles, with each cycle lasting 21 days. The primary outcome timeframe is stated as 6 months after enrollment of the last participant. The secondary outcome listed is median time to progression.
The registry states that participants with evaluable or measurable tumor who completed 2 courses of treatment were to be included in the primary response analysis. It does not report the number who met those criteria or explain how participants who did not complete the required treatment were handled. The statistical analysis plan, sample-size justification, interim-analysis procedures, and detailed conduct of masking are not reported in the registry record.
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.
Overall Study
| Stage | Gemcitabine and Docetaxel |
|---|---|
| STARTED | 20 |
| COMPLETED | 20 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Participants with evaluable or measurable tumor, who complete 2 courses of treatment will be included in analysis of tumor response.
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.
| Characteristic | Unit | Gemcitabine and Docetaxel |
|---|---|---|
| Participants analysed | 20 | |
| Age, Continuous: Between 43 and 75 years | years | 59 (43 to 75) |
| Sex: Female, Male: Female | Participants | 20 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 13 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 7 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 4 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 4 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 12 |
| Region of Enrollment: United States | participants | 20 |
6. Primary Endpoint
The registry lists the primary outcome as Tumor Response Type: CR, PR, SD or PD, measured over 6 months after enrollment of last participant.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint classifies tumor response as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). Under the stated RECIST v1.0 criteria, CR means disappearance of all target lesions. PR is a decrease of at least 30% in the sum of the longest diameters of target lesions. SD is described as less than a 30% decrease or less than a 20% increase. PD is an increase of at least 20% in the longest diameter of target lesions. For participants whose only evidence of disease was an elevated CA-125, the registry defines PR as a decrease of 50% or more lasting at least 8 weeks. Responders were defined as those with CR or PR.
Response categories offer a structured way to describe changes in measurable disease. They distinguish tumor shrinkage meeting the response threshold from lesser changes, stability, or progression. In general, a prespecified response definition can make outcome classification more consistent across participants. It does not, on its own, show whether a treatment caused the response, how durable responses were beyond the stated criteria, or whether participants experienced other benefits or harms.
The assessment timeframe is 6 months after enrollment of the last participant, and the record says disease assessment occurred every 2 cycles, with each cycle lasting 21 days. The primary endpoint is reported in participants, but the response counts and analysis estimate are not reported in the registry record. The record also does not state how unevaluable assessments were classified.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the design and the intended outcome definition, but it does not report the primary tumor-response results. Consequently, it is not possible to describe how many participants had CR, PR, SD, or PD, or to estimate the proportion classified as responders. The record’s definition of responders includes CR and PR, but a definition is not a result. Without the observed response counts and analysis denominator, there is no basis for interpreting the frequency or precision of response in this study.
The analysis population was specified as participants with evaluable or measurable tumor who completed 2 courses of treatment. The registry reports enrollment of 20 but does not state how many participants satisfied that eligibility for the response analysis. Enrollment and an endpoint-specific analysis population are not necessarily interchangeable. The registry record does not report exclusions from the response analysis, missing assessments, or the handling of participants who discontinued before completing the required treatment.
The design also limits what could be inferred even if response results were available. This was a single-group, non-randomized study without a concurrent control. A response observed after treatment could be described, but the design would not separate treatment effects from other explanations, such as the course of the disease, participant selection, or assessment-related factors. The registry does not report an adjusted comparison or a causal-effect estimate.
Adverse-event information is reported separately from the primary tumor-response outcome. The record lists 12 participants affected by serious adverse events among 20 at risk, and 13 affected by other adverse events among 20 at risk. The listed serious-event terms include neutrophil count decreased at 55.0%, white blood cell decreased at 25.0%, and febrile neutropenia at 10.0%, with other listed terms at 5.0%. These figures describe the registry’s safety entries; they do not establish comparative risk because no control group is present. The record does not report deaths in the adverse-event summary.
In general, estimates from a study are more informative when their denominators, uncertainty, and analysis population are clear. Those details are not available for the primary response outcome in the registry record. The absence of reported response results should not be interpreted as evidence of either response or lack of response.
9. Statistical Methods Explained
What does a response category measure?
The primary outcome places each assessed participant into a tumor-response category. CR and PR indicate response under the stated rules, while SD and PD describe other patterns of change. The registry defines responders as participants with CR or PR. This creates a binary responder classification from the four response categories, but the record does not report the counts in those categories or the total number analyzed.
In general, a categorical endpoint can be summarized by counts and proportions in each category. A responder proportion depends on both the number classified as responders and the denominator used for analysis. If participants lack an assessment or do not meet the specified analysis-population criteria, the denominator and handling rules matter. Those response counts, denominator details, and missing-assessment rules are not reported in the registry record.
How should the RECIST rules be understood?
The record specifies RECIST v1.0 and provides thresholds based on target-lesion measurements. CR requires disappearance of all target lesions. PR requires a decrease of at least 30% in the sum of the longest diameters of target lesions. SD is defined using a decrease below 30% or an increase below 20%; PD requires an increase of at least 20% in the longest diameter of target lesions. The record gives a separate PR definition for participants with elevated CA-125 as their only evidence of disease: a decrease of 50% or more lasting at least 8 weeks.
In general, prespecified thresholds reduce reliance on subjective impressions by stating what magnitude and type of change qualifies for a category. They do not eliminate all measurement uncertainty. Tumor measurement, timing of assessments, and whether a participant has lesions that can be evaluated can affect classification. The registry states that disease assessment occurred every 2 cycles, with each cycle lasting 21 days, but does not report details of assessment review or adjudication.
What does a confidence interval add?
In general, a confidence interval expresses the uncertainty around an estimate under a specified statistical model and method. For a response proportion, it would help readers judge how precisely the observed proportion is estimated. A narrow interval indicates greater precision than a wide interval, but neither an interval nor a point estimate resolves the limitations of a single-group design. The registry record does not report a primary response estimate or its confidence interval.
For a comparison between groups, uncertainty around a difference or ratio can describe the range of treatment effects compatible with the data and analysis assumptions. This study has no comparator arm, so a randomized between-group effect is not available from its design. The record does not report a statistical analysis plan or an alternative comparative analysis.
What do the planning illustrations represent?
The planning illustrations are described as calculations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They consider an effect stated as a fraction of the observed effect. In general, such calculations describe the number of participants per arm that a hypothetical future comparison might require under its assumptions. They are planning illustrations, not observed power and not evidence that the present trial had those design features.
The assumptions differ from this trial’s actual single-group, non-randomized design. The registry record does not report a sample-size justification for the trial, and the planning assumptions should not be read as the trial’s protocol or statistical analysis plan. The record does not state whether any interim analyses were planned or conducted. It also does not report an analysis model for the primary endpoint.
Why does over-dispersion matter generally?
In general, over-dispersion occurs when count data vary more than a statistical model assumes. If it is ignored, standard errors may be too small and confidence intervals may appear more precise than warranted. The registry identifies the primary outcome as a binary-type count of participants with events, but it does not report a model for this endpoint or any over-dispersion assessment. This concept is therefore general context, not a description of an analysis documented for this trial.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 2 outcome measures and identifies tumor response type as the primary outcome; median time to progression is listed as a secondary outcome. It reports zero analyses. The record does not describe a statistical plan for handling multiple outcomes, multiple comparisons, or repeated looks at accumulating data. Whether a multiplicity adjustment was planned or used is not reported in the registry record.
Multiplicity is a general concern when several outcomes or comparisons are examined: the chance of an apparently notable finding can change as the number of statistical questions grows. This does not establish that an adjustment was required or omitted in this trial. The registry does not provide enough analysis detail to assess the issue beyond noting the listed outcomes and the absence of reported analyses.
The primary analysis population is described as participants with evaluable or measurable tumor who completed 2 courses of treatment. The record does not report how many participants were included in that population, how many had missing tumor assessments, or how incomplete follow-up was handled. It does not state whether missing outcomes were excluded, imputed, or treated by another method. Those choices can affect endpoint estimates in general, particularly when missingness is related to disease status or treatment discontinuation, but the registry record does not say whether such patterns occurred.
The registry does not report a detailed analysis population for the secondary time-to-progression outcome, including how progression or censoring was defined. Sample-size justification and interim-analysis plans are also not reported in the registry record. Without those details and the outcome analyses, statistical significance, precision, and the effects of missing data or multiplicity cannot be evaluated.
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 |
|---|---|---|---|
| Gemcitabine and Docetaxel | 12 | 20 | 60.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Gemcitabine and Docetaxel | 13 of 20 |
Most frequent serious adverse event terms
| Event term | Organ system | Gemcitabine and Docetaxel |
|---|---|---|
| Neutrophil Count Decreased | Investigations | 11 of 20 |
| White Blood Cell Decreased | Investigations | 5 of 20 |
| Febrile Neutropenia | Blood and lymphatic system disorders | 2 of 20 |
| Alkaline Phosphatase Increased | Investigations | 1 of 20 |
| Anemia | Blood and lymphatic system disorders | 1 of 20 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 1 of 20 |
| Fatigue | General disorders | 1 of 20 |
| Hyperglycemia | Metabolism and nutrition disorders | 1 of 20 |
| Hypoalbuminemia | Metabolism and nutrition disorders | 1 of 20 |
| Hypophosphatemia | Metabolism and nutrition disorders | 1 of 20 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Gemcitabine and Docetaxel |
|---|---|---|
| White Blood Cell Decreased | Investigations | 10 of 20 |
| Fatigue | General disorders | 7 of 20 |
| Platelet Count Decreased | Investigations | 7 of 20 |
| Peripheral Sensory Neuropathy | Nervous system disorders | 6 of 20 |
| Alopecia | Skin and subcutaneous tissue disorders | 5 of 20 |
| Nausea | Gastrointestinal disorders | 4 of 20 |
| Rash/Acneiform | Skin and subcutaneous tissue disorders | 4 of 20 |
| Localized Edema | General disorders | 4 of 20 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 3 of 20 |
| Diarrhea | Gastrointestinal disorders | 3 of 20 |
Serious events with the highest arm-level rate: neutrophil count decreased (55.0%), white blood cell decreased (25.0%), febrile neutropenia (10.0%), alkaline phosphatase increased (5.0%), anemia (5.0%).
The adverse-event record lists 20 participants at risk for serious adverse events and 12 affected. For other adverse events, it lists 20 at risk and 13 affected. These are registry counts for the single treatment group; there is no comparator group for judging relative risk. The record does not report deaths in this summary.
The most frequently listed serious-event term is neutrophil count decreased at 55.0%, followed by white blood cell decreased at 25.0% and febrile neutropenia at 10.0%. Alkaline phosphatase increased, anemia, and dyspnea are each listed at 5.0%. These percentages are reported as serious-event terms in the registry. They should not be added together: the record does not state that the terms are mutually exclusive, and a participant may be represented in more than one event category.
In general, adverse-event counts describe events recorded under a study’s definitions and reporting procedures. A serious adverse event is not synonymous with every adverse event, and the registry’s serious and other adverse-event summaries are separate entries. The record does not provide event-level timing, duration, severity grading, attribution, or the number of episodes per participant. The figures therefore do not establish how events related to treatment or how they compare with another regimen.
12. What the Result Does, and Does Not, Mean
The registry record documents a completed phase II study of docetaxel with gemcitabine in platinum-resistant ovarian cancer and primary peritoneal carcinoma. It specifies a single-group design, the planned treatment schedule, and a primary tumor-response endpoint based on RECIST v1.0 with a stated responder definition. It also reports serious and other adverse-event counts and selected serious-event terms.
Those details do not establish the frequency of tumor response in the study. Although the endpoint and responder criteria are described, the registry record does not report the CR, PR, SD, or PD results, the number of responders, or a response estimate with uncertainty. The absence of these results in the record is not evidence that participants did or did not respond.
Even a reported response rate from a single-group study would describe outcomes among the analyzed participants rather than provide a randomized comparison. Without a concurrent control group, differences attributable to treatment cannot be separated from other explanations using this design alone. The registry record also does not supply enough information to assess the effect of missing assessments on the primary outcome.
The adverse-event figures indicate that the registry recorded serious and other adverse events among participants in the treatment group. They do not by themselves establish causation or comparative safety. The listed percentages are event-term entries, and the record does not explain whether participants could appear under multiple terms.
The study record can therefore support a description of the design, endpoint definitions, and reported safety entries. It cannot support a conclusion about treatment efficacy, comparative benefit, or comparative harm from the information recorded. The primary response results and detailed statistical analysis are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial illustrates why study design and outcome reporting have to be read together. The registry specifies a clinically interpretable endpoint, with response categories and thresholds, and identifies the population intended for response analysis. Those definitions help clarify what would count as a response. They do not substitute for reporting the observed category counts, analysis denominator, or uncertainty.
The single-group design is central to interpretation. In general, a control group helps distinguish outcomes associated with an intervention from outcomes that might occur for other reasons. Here, no concurrent control is present, and allocation is non-randomized. Any results from the treatment group would therefore be descriptive rather than a randomized estimate of comparative effect. The registry record does not report the primary response results in any case.
The record also highlights the importance of specifying analysis populations. The primary response analysis was intended to include participants with evaluable or measurable tumor who completed 2 courses of treatment, while enrollment is reported separately. Without the number included in the endpoint analysis and the handling of missing assessments, readers cannot assess how representative the analyzed group would be of those enrolled.
Finally, the safety counts are useful as recorded event information but cannot establish comparative risk in the absence of a control group. A statistical reading must keep the endpoint definitions, analysis population, missing-data rules, and study design in view. The available registry information describes some of these elements, but leaves the primary outcome analysis and several statistical methods unreported.
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 for interpreting the primary endpoint is that the registry record does not report the response results. It gives the endpoint definition and timeframe but not the numbers classified as CR, PR, SD, or PD, the responder count, the analysis denominator, or an uncertainty estimate. No primary response effect can be summarized from the record.
The study was single-group, non-randomized, and unmasked. Without a control group, the design cannot provide a randomized treatment comparison. The record does not report a statistical analysis plan, sample-size justification, interim analyses, or detailed methods for the endpoint analysis.
The response analysis population was restricted to participants with evaluable or measurable tumor who completed 2 courses of treatment. The registry does not report how many participants met these criteria or how those not meeting them were handled. Missing assessments, withdrawals, and other reasons for exclusion are not described. The stated assessment schedule and response criteria do not resolve these reporting gaps.
The secondary outcome is median time to progression, but its result and analysis details are not reported in the registry record. The safety summary lists counts and selected serious-event terms, but does not provide event timing, duration, severity grading, attribution, or a comparison group. The record also does not report deaths in its adverse-event summary. These limitations constrain both efficacy and safety interpretation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Clinical Trial of Docetaxel in Combination With Gemcitabine in Platinum-Resistant Ovarian Cancer and Primary Peritoneal Carcinoma — NCT00183794.
- Registry record last updated 2014-05-22; status last verified 2012-12.
- Results first posted 2013-01-25.
- 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
The registry describes a completed phase II, non-randomized, unmasked, single-group study of docetaxel and gemcitabine for platinum-resistant ovarian cancer and primary peritoneal carcinoma. Enrollment is listed as 20. The study start is recorded as 2002-11 and primary completion as 2009-05.
The primary endpoint was tumor response type using RECIST v1.0, with CR and PR defined as responders. The intended response population comprised participants with evaluable or measurable tumor who completed 2 courses of treatment. Median time to progression was listed as a secondary outcome.
The registry reports serious adverse events affecting 12 of 20 at risk and other adverse events affecting 13 of 20 at risk. It does not report the primary response results, detailed statistical analyses, or the handling of missing primary-outcome data. The record therefore supports a description of the trial design and reported safety entries, but not an estimate of tumor response or a comparative treatment effect.