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 Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer (NCT00083122), a non-randomized phase 2 study. The primary outcome is Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00083122 |
| Phase | Phase 2 |
| Condition | Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer, Stage IIIA Ovarian Epithelial Cancer |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 45 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
People with advanced or recurrent ovarian epithelial cancer or primary peritoneal cancer. The listed conditions include recurrent disease and stage IIIA, IIIB, IIIC, and IV disease. The registry record says all 45 participants were analyzed for the primary endpoint; further details about the analyzed population are not reported in the registry record.
Intervention
Cisplatin together with flavopiridol. The arm descriptions specify cisplatin given intravenously over 30 minutes and flavopiridol given intravenously over 24 hours on day 1, with courses repeating every 3 weeks if disease had not progressed and toxicity was acceptable.
Comparator
The trial is listed as non-randomized and has parallel groups. Group 1 and Group 2 have identical treatment descriptions. The registry record does not describe a separate control treatment, and the groups should not be read as a randomized, like-for-like treatment comparison.
Primary question
What proportion of participants had a confirmed complete or partial tumor response by 24 weeks? A response required the specified tumor-status criteria to be met on consecutive evaluations. The registry record does not report the observed response proportion, so the answer to that question cannot be quantified from the posted results.
The clinical question is about response during treatment with the drug combination, not about a randomized comparison of the combination with another treatment. The listed secondary outcomes are overall survival and time to progression, but their results are not reported in the registry record. The title and summary describe the trial as studying cisplatin with flavopiridol in advanced ovarian epithelial or primary peritoneal cancer. The posted information does not establish how the two groups differed, if they differed in any way, or whether each group was intended to address a separate question. Because both group descriptions give the same regimen and the allocation is non-randomized, a difference between groups should not be interpreted as a treatment effect.
3. Trial Design
This is a completed phase II trial with a parallel, non-randomized design and no masking. The registry record lists enrollment of 45 participants. The start date is 2004-04, and primary completion is recorded as 2010-07. The sponsor is the National Cancer Institute (NCI). These details describe the trial’s record, but do not provide a basis for inferring its protocol choices or how the treatment was evaluated beyond the information explicitly posted.
The two groups are both described as receiving cisplatin and flavopiridol on day 1. Cisplatin is described as an intravenous infusion over 30 minutes and flavopiridol as an intravenous infusion over 24 hours. Courses are described as repeating every 3 weeks in the absence of disease progression or unacceptable toxicity. The groups’ treatment descriptions are identical in the registry record. Any further distinction between Group 1 and Group 2 is not reported in the registry record.
Non-randomized allocation means the record does not describe chance assignment to treatment groups. Without randomization, differences between groups could reflect factors other than treatment, and the posted record does not establish that the groups are comparable. Here, the identical regimen descriptions also mean the groups cannot be treated as distinct treatment options on the basis of the posted information. The trial is not a masked comparison.
The primary endpoint is the proportion of participants with a confirmed complete or partial response, assessed over 24 weeks. All 45 participants are stated to have been analyzed for that endpoint, but the response result is not reported in the registry record. No analysis records are listed. A sample-size justification, planned interim analyses, detailed statistical plan, and reasons for the group structure 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.
Before assignment: Participants who progressed or relapsed during or within 6 months of primary platinum-based therapy constituted Group 1 ("Platin Resistant"). Participants who relapsed \> 6 months following completion of platinum-based therapy, and who had received only a single prior chemotherapy regimen constituted Group 2 ("Platin Sensitive").
Overall Study
| Stage | Group 1 (Platin Resistant) | Group 2 (Platin Sensitive) |
|---|---|---|
| STARTED | 40 | 5 |
| COMPLETED | 40 | 5 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: All 45 participants were analyzed.
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 | Group 1 (Platin Resistant) | Group 2 (Platin Sensitive) | Total |
|---|---|---|---|---|
| Participants analysed | 40 | 5 | 45 | |
| Age, Continuous | years | 59 (29 to 79) | 61 (41 to 73) | 59 (29 to 79) |
| Sex: Female, Male: Female | Participants | 40 | 5 | 45 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 40 | 5 | 45 |
6. Primary Endpoint
The registry lists the primary outcome as Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR), measured over 24 weeks.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Percentage of Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants with a confirmed tumor response, where response means either a complete response or a partial response. The endpoint is assessed over 24 weeks. A complete response is defined as disappearance of all target lesions and normalization of tumor biomarkers. A partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions relative to the baseline sum. A response is confirmed when the objective status is recorded on consecutive evaluations at least 4-6 weeks apart.
This is a binary outcome at the participant level: each participant either meets the response definition or does not. Reporting a proportion gives a concise account of how often the defined response occurred in the analyzed group. The confirmation requirement is intended to distinguish a response observed at consecutive assessments from a status noted on only one evaluation. The endpoint definition therefore specifies both the tumor-change criteria and the required confirmation timing.
The registry record identifies the endpoint and states that all 45 participants were analyzed, but it does not report the number or percentage with confirmed response. It also does not report an uncertainty interval or a statistical test for this endpoint. Consequently, the endpoint’s numerical result and precision cannot be assessed from the registry record. The listed secondary outcomes, overall survival and time to progression, are distinct from this response endpoint; their results are also not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a phase II study of cisplatin and flavopiridol in advanced ovarian epithelial or primary peritoneal cancer. It specifies a primary endpoint based on confirmed complete or partial tumor response over 24 weeks and states that all 45 participants were analyzed. However, the numerical response result is not reported in the registry record. Without that result, readers cannot determine the observed proportion of participants meeting the endpoint or how precisely it was estimated.
A percentage alone would describe the frequency of the defined response in the analyzed participants. A confidence interval, if reported, would convey statistical uncertainty around that estimate: narrower intervals indicate greater precision, while wider intervals indicate less precision. Neither the response estimate nor an interval is reported in the registry record. No p-value or analysis entry is listed, so there is no posted inferential result to interpret for the primary endpoint.
The design also limits what can be concluded. Allocation is non-randomized, masking is absent, and the two group descriptions specify the same regimen. The record does not identify a distinct control treatment. These features do not support interpreting the groups as a randomized comparison or attributing a difference between them to treatment. The record also does not report group-specific endpoint results, so no group comparison can be described.
Overall survival and time to progression are listed as secondary outcomes, but no results for either outcome are reported in the registry record. Their presence in the outcome list does not establish that an effect was observed, that an analysis was completed, or that the results favored any particular interpretation.
The serious adverse-event information is separate from the missing efficacy result. For the combined groups, the record lists 45 participants at risk and 23 affected for serious adverse events. It also lists serious-event terms with percentages, including nausea and dehydration at 8.9% each. These figures describe the posted safety reporting; they do not fill in the missing primary response result or establish a comparative safety effect. Taken together, the record provides endpoint definitions, treatment descriptions, and some adverse-event reporting, but not enough outcome information to quantify response or its uncertainty.
9. Statistical Methods Explained
The primary endpoint is a binary participant-level outcome. Each participant is classified according to whether a confirmed complete or partial tumor response meets the registry’s stated criteria. The resulting proportion is a descriptive summary: it represents the share of the analyzed participants who met the definition. General statistical interpretation of such a proportion depends on both its estimate and the amount of information available. The registry record states that all 45 participants were analyzed, but does not report the number meeting the endpoint or the estimated percentage.
What does a confidence interval add?
In general, a confidence interval describes the statistical uncertainty around an estimate. It is not a guarantee that the true value lies within the interval, nor does it measure the range of individual participant outcomes. For a response proportion, an interval would help readers judge how precisely the observed proportion estimates response frequency in a broader population resembling the participants studied. The width of an interval depends on the estimate and the amount of information. No confidence interval for the primary endpoint is reported in the registry record, so its precision cannot be evaluated.
What does the endpoint definition contribute?
The definition determines which participant outcomes count as responses. Here, a complete response requires disappearance of all target lesions and normalization of tumor biomarkers. A partial response requires at least a 30% decrease in the sum of the longest diameters of target lesions relative to baseline. Either status must be recorded on consecutive evaluations at least 4-6 weeks apart to count as a confirmed response. This confirmation rule is part of the endpoint itself, not a statistical adjustment. If assessment timing, missing evaluations, or handling of unevaluable participants affects classification, those details would matter for interpretation; they are not reported in the registry record.
How should the design shape interpretation?
In general, random allocation can help balance measured and unmeasured participant characteristics across treatment groups. This trial is listed as non-randomized, so the record does not describe that protection against imbalance. The parallel structure indicates groups are followed in the same trial, but does not by itself establish that they are comparable. Both group descriptions list the same regimen, and the registry record does not describe a distinct control treatment. Therefore, the group labels do not establish a treatment contrast, and the design information does not support causal interpretation of a between-group difference.
Masking is listed as none. In general, masking can reduce the influence of knowledge about treatment assignment on some aspects of assessment or reporting. Its absence does not by itself show that an outcome assessment was biased, but it is relevant context, particularly when an endpoint depends on clinical evaluations. The record does not describe additional procedures used to standardize or independently review response assessments.
What can be said about the analysis plan?
The registry record lists no analysis entries. A detailed statistical analysis plan, the method used to estimate the response proportion, any confidence-interval method, interim analyses, and handling of missing or unevaluable endpoint assessments are not reported in the registry record. The statement that all 45 participants were analyzed does not specify how each participant’s outcome was classified or how missing assessments were handled.
General methods for binary outcomes can estimate a proportion and quantify uncertainty around it. More complex methods may be appropriate when outcomes are clustered, repeatedly measured, or otherwise depart from a simple participant-level structure. The registry endpoint is defined as a participant-level response, but further details on the statistical model are not reported. Over-dispersion is a general concern when variation exceeds what a chosen probability model expects; there is no basis in the registry record to claim that over-dispersion was assessed or that a particular model was used.
The sample-size planning assumptions describe illustrations using a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation, with target effects expressed as fractions of the observed effect. Such calculations are planning illustrations, not observed power and not evidence that the trial was designed with those assumptions. The trial’s own sample-size justification is not reported in the registry record. The observed primary effect is also not reported there, so the planning figures cannot be interpreted as a substitute for the trial’s outcome result.
How do the secondary outcomes fit?
Overall survival and time to progression are listed as secondary outcomes. These are time-to-event outcomes, which generally require information about follow-up time and the timing of events, as well as methods that account for participants whose event status is not observed by the end of follow-up. The registry record does not report results, follow-up summaries, event counts, or analysis details for these outcomes. No conclusions about them can be drawn from their listing alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists a primary response endpoint and the secondary outcomes overall survival and time to progression. It does not report a multiplicity strategy, such as whether any adjustment was planned for evaluating multiple outcomes or multiple comparisons. A detailed statistical analysis plan and analysis entries are not reported in the registry record. It is therefore not possible to determine how the trial handled the possibility of false-positive findings arising from examining multiple outcomes.
In general, multiplicity refers to the increased chance of at least one misleading statistical signal when several hypotheses are tested. A prespecified strategy can clarify which outcome is primary, how secondary outcomes are interpreted, and whether statistical thresholds are adjusted. The registry identifies a primary endpoint, but the remaining details of such a strategy are not reported in the registry record. The listed secondary outcomes should consequently be treated as named outcomes, not as evidence of statistically supported effects.
The record states that all 45 participants were analyzed for the primary endpoint. It does not report how missing assessments, participants without an evaluable response, withdrawals, or other incomplete outcome data were handled. A stated analysis population does not, by itself, describe the completeness of the underlying measurements or the rules used to classify participants. Missing-data methods, sensitivity analyses, and reasons for any missing endpoint assessments are not reported in the registry record.
These omissions matter because the response outcome depends on evaluations over time and on confirmation at consecutive assessments. Without information about assessment completeness and handling of unevaluable cases, readers cannot assess whether the reported analysis population reflects complete endpoint data. In this record, the primary response result itself is not reported, further limiting evaluation of both the analysis and its uncertainty.
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 |
|---|---|---|---|
| Group 1 and Group 2 Combined | 23 | 45 | 51.1% |
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 |
|---|---|
| Group 1 and Group 2 Combined | 45 of 45 |
Most frequent serious adverse event terms
| Event term | Organ system | Group 1 and Group 2 Combined |
|---|---|---|
| Nausea | Gastrointestinal disorders | 4 of 45 |
| Dehydration | Metabolism and nutrition disorders | 4 of 45 |
| Small intestinal obstruction | Gastrointestinal disorders | 3 of 45 |
| Vomiting | Gastrointestinal disorders | 3 of 45 |
| Hypersensitivity | Immune system disorders | 3 of 45 |
| Abdominal pain | Gastrointestinal disorders | 2 of 45 |
| Fatigue | General disorders | 2 of 45 |
| Fever | General disorders | 2 of 45 |
| Serum magnesium decreased | Metabolism and nutrition disorders | 2 of 45 |
| Serum potassium decreased | Metabolism and nutrition disorders | 2 of 45 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Group 1 and Group 2 Combined |
|---|---|---|
| Fatigue | General disorders | 44 of 45 |
| Hemoglobin decreased | Blood and lymphatic system disorders | 42 of 45 |
| Nausea | Gastrointestinal disorders | 42 of 45 |
| Neutrophil count decreased | Investigations | 33 of 45 |
| Peripheral sensory neuropathy | Nervous system disorders | 33 of 45 |
| Vomiting | Gastrointestinal disorders | 32 of 45 |
| Blood glucose increased | Metabolism and nutrition disorders | 32 of 45 |
| Diarrhea | Gastrointestinal disorders | 31 of 45 |
| Platelet count decreased | Investigations | 28 of 45 |
| Serum magnesium decreased | Metabolism and nutrition disorders | 24 of 45 |
Serious events with the highest arm-level rate: nausea (8.9%), dehydration (8.9%), small intestinal obstruction (6.7%), vomiting (6.7%), hypersensitivity (6.7%).
For the combined groups, the serious adverse-event reporting lists 45 participants at risk and 23 affected. The record also lists 45 participants at risk and 45 affected for other adverse events. These are separate reporting categories in the posted data. The figures describe participants recorded as affected; they should not be interpreted as counts of distinct event episodes or as a comparison between treatments. The groups are combined for these figures, and their treatment descriptions are identical.
The listed serious adverse-event terms are nausea at 8.9%, dehydration at 8.9%, small intestinal obstruction at 6.7%, vomiting at 6.7%, hypersensitivity at 6.7%, and abdominal pain at 4.4%. These percentages are reported as term-level figures. The registry record does not provide further details about event timing, duration, severity grading, recurrence, or attribution to treatment. It also does not report a death count in the serious adverse-event summary.
Serious adverse events and other adverse events are not interchangeable categories. These figures should be read as registry safety reports, not as proof that an event was caused by the regimen or as evidence for a comparative safety conclusion. Because there is no separate control treatment described, the combined figures do not establish how safety would differ under another treatment.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed phase II trial evaluated cisplatin with flavopiridol in participants with advanced ovarian epithelial or primary peritoneal cancer. It describes the treatment schedule, defines a confirmed tumor response endpoint, identifies overall survival and time to progression as secondary outcomes, and reports some serious adverse-event information. It also states that all 45 participants were analyzed for the primary endpoint.
Those details do not establish the trial’s primary response result. The observed proportion of participants with a confirmed response, its uncertainty, and any inferential analysis are not reported in the registry record. The secondary outcome results are not reported either. As a result, the posted record cannot show how often the primary outcome occurred or how precisely it was estimated. It cannot support a conclusion about the magnitude or direction of an effect on survival or time to progression.
The design also does not provide a randomized comparison. Allocation is non-randomized, masking is absent, and Group 1 and Group 2 have identical treatment descriptions. A comparison between those group labels would not establish that any difference was caused by treatment. The registry record does not describe a separate control treatment or explain the reason for having the two groups.
The safety percentages and affected-participant figures are useful descriptions of what the record reports, but they do not provide a complete account of adverse events or establish causation. The posted information does not give enough detail to evaluate event timing, treatment attribution, or comparative safety. The absence of a reported primary result should not be treated as evidence that no responses occurred; it means the registry record does not report the result needed to assess response. Overall, the record documents the trial’s design and selected outcomes, while leaving the main efficacy estimate and several important analysis details unreported.
13. Why This Trial Matters Statistically
This trial illustrates why an endpoint definition and an endpoint result are both necessary for statistical interpretation. The registry gives a detailed definition of confirmed complete or partial response, including tumor-change criteria and a confirmation interval. That definition clarifies what was intended to count as a response. Yet without the observed response proportion and an uncertainty interval, readers cannot assess the frequency or precision of the outcome.
It also shows why design labels matter. A parallel-group description does not automatically mean that groups are randomized or comparable. This study is explicitly non-randomized, and both groups are described as receiving the same combination. Those details constrain what a group comparison could mean and prevent readers from treating the group labels as a randomized control contrast.
The record further distinguishes outcome availability from analysis transparency. It names overall survival and time to progression, but does not report their results or analysis details. It states that all 45 participants were analyzed for the primary endpoint, while leaving missing-data handling and the statistical analysis plan unreported. Those gaps make it difficult to evaluate how the endpoint definition was applied in practice.
Finally, the safety information demonstrates the importance of keeping event categories and denominators clear. Serious adverse-event reporting and other adverse-event reporting are separate, and term-level percentages should not be conflated with treatment comparisons or causal findings. The statistical lesson is not a conclusion about treatment efficacy: it is that trial design, endpoint definitions, numerical estimates, uncertainty, and analysis details all contribute to what a registry record can support.
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 most direct limitation is that the registry record does not report the primary endpoint result. Although it defines confirmed response and states that all 45 participants were analyzed, it gives no response count, percentage, confidence interval, or test result. The primary question therefore cannot be answered quantitatively from the posted record.
The trial is non-randomized and unmasked. Its groups have identical treatment descriptions, and no distinct control treatment is described. The record does not explain why the groups were separated or whether other characteristics differed between them. These registry entries limit interpretation of any group-level comparison and do not support a randomized treatment-effect claim.
Important analysis details are also absent. A statistical analysis plan, sample-size justification, interim-analysis plan, method for estimating the primary proportion, and handling of missing or unevaluable response assessments are not reported in the registry record. Although all 45 participants are said to have been analyzed, the record does not explain the completeness of response assessments or how the confirmation requirement was applied when evaluations were missing.
The listed secondary outcomes have no posted results or analysis details. Safety reporting is combined across groups and does not include the event-level context needed to evaluate timing, duration, attribution, or a comparison with another treatment. These limitations are specific to the information available in the registry record and prevent a fuller assessment of efficacy, precision, and comparative safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer — NCT00083122.
- Registry record last updated 2014-05-21; status last verified 2013-04.
- Results first posted 2013-05-14.
- 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 record describes a completed phase II, parallel, non-randomized, unmasked trial of cisplatin and flavopiridol in advanced ovarian epithelial or primary peritoneal cancer. Enrollment is listed as 45, and all 45 participants are stated to have been analyzed for the primary endpoint.
The primary endpoint is the percentage of participants with a confirmed complete or partial tumor response over 24 weeks. Overall survival and time to progression are listed as secondary outcomes. The primary response result and the secondary outcome results are not reported in the registry record.
Both group descriptions specify the same cisplatin and flavopiridol regimen. Serious adverse-event reporting is combined across groups and lists 23 affected among 45 at risk. The registry record does not report a detailed statistical analysis plan, missing-data handling, or the trial’s sample-size justification.