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 Ixabepilone to Treat Cervical Cancer (NCT00924066), a na phase 2 study. The primary outcome is Number of Participants With a Tumor Response (PR + CR) Per RECIST.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00924066 |
| Phase | Phase 2 |
| Condition | Cervical Carcinoma, Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 41 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
The registry record concerns women aged 18 years or older with cervical cancer. Conditions listed include cervical carcinoma, cervical adenocarcinoma, cervical adenosquamous carcinoma, and non-squamous cervical carcinoma. The arm description refers to squamous and non-squamous participants. The record lists enrollment of 41, but the reported primary outcome does not give a response count or clarify the number evaluated for that endpoint.
Intervention
The intervention was ixabepilone, also named Ixempra and BMS-247550 in the registry record. The treatment description specifies an intravenous infusion over 60 minutes on the first 5 days of each 21-day cycle. Dose adjustment could depend on how participants responded to the drug, and the number of cycles depended on treatment response.
Comparator
No comparator group is recorded. The study model is single-group, and allocation is listed as not applicable. The record therefore does not describe a randomized comparison against another treatment or a control group. This limits what can be concluded by comparing outcomes within the trial.
Primary question
The primary question was whether participants had a complete or partial tumor response according to RECIST. Complete response meant disappearance of all target lesions; partial response required at least a 30% decrease in the sum of target-lesion longest diameters relative to baseline. The registry record does not report how many participants had either response, so the response outcome cannot be quantified from the posted results.
3. Trial Design
The registry record describes a phase II, single-group study of ixabepilone in cervical cancer. Enrollment is listed as 41. Allocation is not applicable, and masking is listed as none. With no comparator group recorded, the design does not provide a randomized, like-for-like comparison against another treatment. The record lists the study as terminated; it does not report the reason for termination.
The treatment description specifies ixabepilone by intravenous infusion over 60 minutes on days 1–5 of each 21-day cycle. Dose could be adjusted according to participants’ responses to the drug, and the number of cycles depended on treatment response. Tumor assessments were planned before treatment and every other cycle using CT scans and other tests. The primary outcome timeframe is every 6 weeks, up to 15 months.
The registry describes optional tumor biopsies before treatment and on the fourth or fifth treatment day for participants able to undergo biopsy. It does not report how many biopsies were performed or their findings. The record lists a start of 2008-11 and primary completion of 2013-12. The population, treatment schedule, and assessment plan describe the study’s intended clinical setting, but do not establish how consistently each procedure occurred. The number who received treatment, completed follow-up, or contributed evaluable scans is not reported in the registry record.
The design can describe outcomes among participants receiving the study treatment, but without a concurrent comparison group it cannot separate treatment-associated outcomes from other explanations. The registry record does not report details of a statistical analysis plan, sample-size justification, or interim analyses.
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 | Squamous and Nonsquamous Participants |
|---|---|
| STARTED | 41 |
| COMPLETED | 41 |
| NOT COMPLETED | 0 |
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 | Squamous and Nonsquamous Participants |
|---|---|---|
| Participants analysed | 41 | |
| Age, Continuous | years | 46.79 (SD 9.17) |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 40 |
| Age, Categorical: >=65 years | Participants | 1 |
| Sex: Female, Male: Female | Participants | 41 |
| Sex: Female, Male: Male | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 3 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 4 |
| Race (NIH/OMB): White | Participants | 34 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 3 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 37 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| Region of Enrollment: United States | Participants | 41 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With a Tumor Response (PR + CR) Per RECIST, measured over Every 6 weeks, up to 15 months.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with a complete or partial tumor response according to RECIST. It is a count outcome: the registry defines the result as the number of participants meeting either response category, rather than a continuous measure of tumor size. Complete response requires disappearance of all target lesions. Partial response requires at least a 30% decrease in the sum of the longest diameters of target lesions, compared with the baseline sum.
The registry also defines progressive disease as at least a 20% increase from the smallest sum recorded since treatment began, or the appearance of new lesions. Stable disease means the observed change meets neither the criteria for partial response nor those for progressive disease. Not evaluable means there is no scan available for comparison with the baseline scan. These definitions help distinguish tumor-response categories using a prespecified measurement framework.
In general, an objective tumor-response endpoint can describe whether measured lesions crossed defined response thresholds during follow-up. It does not, by itself, describe how long a response lasted or establish a comparison with an untreated or alternative-treatment group. Although the registry lists the endpoint and its timeframe, it does not report the response count, category breakdown, or analysis. The posted results therefore do not show how many participants met the primary endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a primary outcome of participants with complete or partial response by RECIST, assessed every 6 weeks up to 15 months. However, it does not report a result for that endpoint. No response count, response estimate, confidence interval, or test result is available in the registry record. As a result, the primary outcome cannot be interpreted as evidence for or against a difference in tumor response.
The study is listed as phase II and single-group, with no masking and no comparator. These design features matter when interpreting any outcomes: a single-group result would describe what was observed among participants in the study, but would not directly compare ixabepilone with another treatment. Without a control group, differences in participant characteristics, disease course, assessment timing, and other factors cannot be addressed through a randomized between-group contrast. The registry record does not report an adjusted analysis that might address such factors.
Enrollment is listed as 41, but that figure does not establish how many participants received treatment, had follow-up scans, or were evaluable for the primary endpoint. The record defines a not-evaluable category for participants without a scan to compare with baseline, but does not report how many were not evaluable. It also does not provide a flow of participants through treatment and outcome assessment. Accordingly, the enrolled number should not be treated as the denominator for a response estimate.
The registry lists a safety summary separately. It reports 41 participants at risk for non-serious adverse events and 41 affected, as well as 41 at risk for serious adverse events and 18 affected. These are reported counts, not a comparison with another group. The record also lists two deaths; it does not establish that they were caused by treatment. Serious adverse-event terms and percentages are descriptive registry entries, not estimates of comparative risk.
The study status is terminated, but the reason for termination is not reported in the registry record. That status alone does not explain whether termination was related to recruitment, safety, efficacy, administrative decisions, or another cause. The primary completion date is recorded as 2013-12, but no primary outcome analysis accompanies it. Overall, the available results characterize some design and safety information, while leaving the central tumor-response result unreported.
9. Statistical Methods Explained
In general, a binary response outcome classifies each participant into whether a defined event occurred or did not occur. Here, the event is having a complete or partial response under the RECIST definitions. The primary outcome is expressed as a count of participants meeting that combined definition. A count is not itself a response rate: interpreting a rate requires an appropriate denominator, such as the number of participants included in the relevant analysis. The registry record gives no primary outcome count or analysis denominator.
What does the RECIST classification capture?
RECIST uses measurements of target lesions and defined rules to classify change. The registry describes complete response as disappearance of all target lesions and partial response as at least a 30% decrease in the sum of longest diameters relative to baseline. Progressive disease is defined by at least a 20% increase from the smallest sum recorded since treatment started, or new lesions. Stable disease lies between the response and progression criteria, while not evaluable applies when a scan is unavailable for comparison with baseline. In general, these categories translate imaging measurements into clinically interpretable response labels. The registry supplies the definitions, but not participant-level measurements or the number falling in each category.
What would uncertainty measures mean?
In general, a confidence interval expresses the range of values reasonably compatible with the data and the statistical method used. Its width reflects precision: wider intervals indicate less precise estimates, while narrower intervals indicate greater precision under the chosen model. A confidence interval for a response proportion would require an observed response count and an analysis denominator, neither of which is reported for this endpoint. No interval is reported in the registry record, so the precision of the primary response result cannot be assessed.
In general, a hypothesis test addresses compatibility between observed data and a specified null hypothesis. A p-value is not the probability that a treatment works, nor does it measure the size or clinical importance of an effect. Interpreting a test also depends on knowing the planned comparison, analysis population, and statistical method. The registry record reports no primary endpoint analysis or p-value, and the statistical plan is not reported in the registry record.
Why does the single-group design matter?
The study model is single-group, and no comparator is recorded. In general, data from a single group can describe the outcomes observed among those participants, but cannot supply a randomized estimate of how outcomes would differ under another treatment or no treatment. Changes over time may reflect factors besides the intervention, including the natural course of disease, participant selection, or differences in assessment. A single-group result should therefore not be interpreted as a controlled treatment effect. No between-group effect estimate is reported.
How should the safety counts be understood?
In general, an adverse-event count describes the number of participants recorded as having an event under the registry’s reporting definitions. Serious and non-serious events are distinct reporting categories. The posted safety summary lists the number at risk and affected for each category, but does not provide a comparative analysis or establish causation. Events can also differ in severity, timing, and relationship to treatment; the registry entries do not supply enough detail to evaluate each dimension. The listed serious-event terms and percentages should be read as descriptive entries rather than a ranking of comparative treatment risks.
The record lists two deaths but does not state their relationship to ixabepilone. A death count alone cannot determine causality. The registry also does not report event timing, participant-level overlap among event categories, or a detailed narrative for each event. These omissions limit interpretation beyond the reported counts and terms.
Are planning assumptions evidence about observed outcomes?
In general, sample-size planning illustrations describe how many participants might be needed under specified assumptions; they are not observed trial results or observed power. The registry record does not report a trial-specific sample-size justification. The available record also does not report an analysis that can be used to assess the primary endpoint’s statistical precision. Any planning calculation should therefore be kept separate from what the study actually observed.
In this trial, the principal methodological constraint is not a particular reported estimate with a wide or narrow interval; it is the absence of a reported primary outcome analysis. The endpoint definitions and study design are available, but the response count, denominator, uncertainty estimate, and inferential result are not reported in the registry record. Statistical methods cannot recover an outcome that is not posted.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists the tumor-response count as the primary outcome and serious and non-serious adverse events as a secondary outcome. It does not report a multiplicity strategy for interpreting more than one outcome or multiple comparisons. The number of outcome measures is listed as 2, but no analyses are reported. The registry record does not say whether any adjustment for multiple testing was planned or used.
The primary outcome definition includes complete and partial response together, while the registry also defines progressive disease, stable disease, and not evaluable. It does not report how many participants fell into these categories. The record defines not evaluable as lacking a scan for comparison with baseline, but does not state how missing scans were handled in an analysis, how many participants lacked scans, or whether any imputation or other missing-data method was used. These details are not reported in the registry record.
The record gives enrollment of 41, but does not identify the analysis population for the primary outcome. It does not report how many participants received treatment, had at least one follow-up scan, or were included in an endpoint analysis. The basis for the reported safety populations is indicated by the at-risk counts, but further analysis-population definitions are not reported in the registry record.
These gaps make it impossible to assess whether missing outcomes or analysis choices could affect the primary result. The absence of a reported analysis should not be interpreted as a finding of no response or no effect; it means that the registry record does not provide the result needed to evaluate that question.
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 |
|---|---|---|---|
| Adverse Events for Squamous and Non-squamous Participants | 18 | 41 | 43.9% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Adverse Events for Squamous and Non-squamous Participants | 2 of 41 |
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 |
|---|---|
| Adverse Events for Squamous and Non-squamous Participants | 41 of 41 |
Most frequent serious adverse event terms
| Event term | Organ system | Adverse Events for Squamous and Non-squamous Participants |
|---|---|---|
| Fever | General disorders | 3 of 41 |
| Urinary tract obstruction | Renal and urinary disorders | 3 of 41 |
| Anemia | Blood and lymphatic system disorders | 2 of 41 |
| Death NOS | General disorders | 2 of 41 |
| Dehydration | Metabolism and nutrition disorders | 2 of 41 |
| Ileus | Gastrointestinal disorders | 2 of 41 |
| Nausea | Gastrointestinal disorders | 2 of 41 |
| Thromboembolic event | Vascular disorders | 2 of 41 |
| Vomiting | Gastrointestinal disorders | 2 of 41 |
| Abdominal pain | Gastrointestinal disorders | 1 of 41 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Adverse Events for Squamous and Non-squamous Participants |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | 41 of 41 |
| Lymphocyte count decreased | Investigations | 41 of 41 |
| Hypoalbuminemia | Metabolism and nutrition disorders | 31 of 41 |
| Hypomagnesemia | Metabolism and nutrition disorders | 25 of 41 |
| Nausea | Gastrointestinal disorders | 25 of 41 |
| Platelet count decreased | Investigations | 25 of 41 |
| Fatigue | General disorders | 23 of 41 |
| Hyponatremia | Metabolism and nutrition disorders | 22 of 41 |
| Alkaline phosphatase increased | Investigations | 21 of 41 |
| Anorexia | Metabolism and nutrition disorders | 19 of 41 |
Serious events with the highest arm-level rate: fever (7.3%), urinary tract obstruction (7.3%), anemia (4.9%), death nos (4.9%), dehydration (4.9%).
The registry safety summary lists 41 participants at risk for serious adverse events and 18 affected. For non-serious adverse events, it lists 41 at risk and 41 affected. These are participant counts in the registry record; they are not comparisons against another treatment group. The record also lists two deaths. It does not report whether those deaths were considered related to ixabepilone.
The serious-event terms listed include fever (7.3%), urinary tract obstruction (7.3%), anemia (4.9%), Death NOS (4.9%), dehydration (4.9%), and ileus (4.9%). These entries describe reported terms and percentages. The registry does not provide enough information to determine whether participants experienced more than one listed event, how events were timed, or how each event was assessed for relationship to treatment. The listed percentages should not be treated as mutually exclusive categories or added together.
In general, adverse-event summaries are descriptive records of events during a study, not proof that treatment caused them. A comparison group and additional clinical context would be needed to interpret relative safety. The registry record does not report a comparative safety analysis.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a phase II, single-group study of ixabepilone in cervical cancer was conducted and that its primary endpoint was a RECIST-defined count of complete or partial tumor responses. It also records enrollment of 41, the treatment schedule, assessment timing, and safety counts. These registry entries describe the study design and some posted results; they do not answer the primary response question.
The central limitation is that the registry does not report the primary response count, its denominator, or a statistical analysis. Consequently, the posted results cannot show the frequency of complete or partial responses, how precisely that frequency was estimated, or whether an analysis supported a particular conclusion. A missing outcome report is not the same as a result of zero responses, and it is not evidence that no response occurred.
The design also has no comparator group, so even a reported single-group response count would not by itself provide a randomized comparison with another treatment. The registry’s safety counts are likewise descriptive; they do not determine whether events were caused by ixabepilone or how risk would compare under another treatment. The reason for the terminated status is not reported in the registry record, so it cannot be used to infer the study’s clinical findings or the cause of termination.
In general, a trial result is most informative when the outcome definition, analysis population, observed estimate, uncertainty, and relevant comparison are all available. For this record, the endpoint definition and several design details are available, but the primary estimate and its uncertainty are not. Interpretation should therefore remain limited to what is explicitly reported, without substituting assumptions for the missing outcome analysis.
13. Why This Trial Matters Statistically
This trial illustrates why a clearly defined endpoint and a reported result are both necessary for statistical interpretation. The registry gives operational RECIST definitions for complete response, partial response, progression, stable disease, and not evaluable status. Such definitions clarify what would count as a response. But without the observed response count and the relevant analysis denominator, those definitions cannot establish how participants actually fared on the endpoint.
The single-group design is also important. A study can describe outcomes among treated participants, but a comparator is needed for a direct estimate of how outcomes differ between treatment strategies. Randomization, when used, can help make such comparisons more interpretable by reducing systematic differences between groups. This record lists no comparator and no allocation, so it cannot support a randomized treatment contrast.
The record additionally demonstrates the distinction between safety reporting and causal interpretation. Counts of participants with events and the listed event terms are useful descriptive information, but they do not by themselves determine attribution or comparative risk. The registry records two deaths without reporting whether they were treatment-related, underscoring the importance of event context and attribution details.
Finally, a terminated status does not explain why a study ended, and an enrollment figure does not reveal how many participants contributed to a specific endpoint. Transparent reporting of participant flow, missing outcomes, analysis populations, statistical methods, and primary results is needed to understand how much confidence to place in a trial estimate. Those elements are not reported for the primary endpoint in this registry record.
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 primary endpoint is defined, but its observed result is not reported in the registry record. There is no response count, denominator, confidence interval, or test result. This prevents assessment of the magnitude and precision of the primary outcome. The record also does not report the number of participants with complete response, partial response, stable disease, progressive disease, or not-evaluable status.
Enrollment is recorded as 41, but participant flow is not reported. The registry does not state how many participants began treatment, completed treatment, had follow-up imaging, or contributed to an endpoint analysis. Although the endpoint definition explains the not-evaluable category, the frequency of missing scans and the approach to missing data are not reported in the registry record.
The design is single-group and unmasked, with no comparator. This precludes a randomized between-group comparison and leaves potential sources of difference over time or across participants unaddressed by a control group. The registry record does not report the statistical plan, sample-size justification, interim analyses, or an adjusted primary outcome analysis. The reason the study was terminated is also not reported.
Safety information is limited to listed counts and terms. The record does not provide a comparative safety analysis or establish causation for the recorded events and deaths. The listed event terms do not describe timing, participant-level overlap, or detailed attribution. These limitations constrain interpretation of both the primary endpoint and the safety results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Ixabepilone to Treat Cervical Cancer — NCT00924066.
- Registry record last updated 2019-11-21; status last verified 2019-11.
- Results first posted 2014-06-09.
- 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
NCT00924066 is recorded as a phase II, single-group study of ixabepilone for cervical cancer, sponsored by the National Cancer Institute. Enrollment is listed as 41; masking is listed as none, and allocation is not applicable. The registry records a start of 2008-11, primary completion of 2013-12, and status of terminated.
The primary endpoint was the number of participants with complete or partial tumor response by RECIST, assessed every 6 weeks up to 15 months. The registry record does not report the primary outcome count or an analysis. Safety entries list 18 participants affected by serious adverse events and 41 affected by non-serious adverse events, with 41 at risk in each category, and two deaths. The reason for termination and the relationship of deaths to treatment are not reported in the registry record.