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 Docetaxel and Flavopiridol in Treating Patients With Refractory Metastatic Pancreatic Cancer (NCT00331682), a na phase 2 study. The primary outcome is Objective Response Rate as Measured by RECIST Criteria.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00331682 |
| Phase | Phase 2 |
| Condition | Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 10 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
Patients with refractory metastatic pancreatic cancer. The listed conditions include adenocarcinoma of the pancreas, recurrent pancreatic cancer, and stage IV pancreatic cancer. Further eligibility details are not reported in the registry record.
Intervention
Docetaxel followed by flavopiridol, also called alvocidib. The treatment description specifies intravenous administration on days 1, 8, and 15, with courses repeating every 28 days unless disease progression or unacceptable toxicity occurs.
Comparator
There is no separate comparator group. This was a non-randomized, single-group study, so its design does not make a like-for-like comparison with another treatment or with usual care.
Primary question
The primary outcome was objective response rate measured by RECIST criteria, with a timeframe of up to 2 years. The registry record does not report the number of participants with an objective response or an estimated response rate.
The clinical question is whether the combination was associated with objective tumor responses among the enrolled patients. Because the study has a single treatment group, it can describe outcomes under the study regimen but cannot isolate the effect of either drug or establish how outcomes compare with a different treatment. The registry record also names time to progression and overall survival as secondary outcomes, but does not report their results. Details such as eligibility criteria beyond the listed conditions, the planned response definition beyond the reference to RECIST, and how response assessments were handled are not reported in the registry record. The available record therefore identifies the question and treatment regimen, but does not give the outcome information needed to estimate the observed response or judge its precision.
3. Trial Design
This was an open-label, non-randomized phase II study with a single treatment group. The registry lists enrollment of 10 and describes treatment with docetaxel followed by flavopiridol, also identified as alvocidib. Neither allocation to alternative treatments nor masking was used. As a result, the design is suited to describing outcomes among patients receiving the regimen, not to a controlled estimate of its comparative effect.
The treatment description specifies docetaxel by intravenous infusion over 30 minutes, followed 4-6 hours later by flavopiridol by intravenous infusion over 60 minutes. Both drugs were scheduled on days 1, 8, and 15, with courses repeating every 28 days in the absence of disease progression or unacceptable toxicity. These are the registry’s stated treatment details; further dose or dose-modification information is not reported in the registry record.
The record identifies the study as phase II and the status as completed. It lists a start of 2006-03 and a primary completion of 2008-05. The National Cancer Institute is listed as sponsor. These registry entries describe the study’s structure and timeline, but they do not supply results for the primary endpoint. The registry record also does not report a statistical analysis plan, a sample-size justification, or whether interim analyses were planned. The enrollment figure should therefore not be interpreted as evidence that the study had adequate precision to estimate response or detect a treatment effect.
With no concurrent control group, outcomes may reflect the studied regimen alongside patient characteristics, disease course, supportive care, and other influences. The design cannot distinguish these influences from the treatment’s contribution. Interpretation should accordingly remain descriptive and should not treat the study as a randomized comparison.
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 | Docetaxel and Flavopiridol |
|---|---|
| STARTED | 10 |
| COMPLETED | 9 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Docetaxel and Flavopiridol |
|---|---|
| Adverse Event | 1 |
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 | Docetaxel and Flavopiridol |
|---|---|---|
| Participants analysed | 9 | |
| Age, Continuous | years | 66 (SD 21.21320344) |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 4 |
| Age, Categorical: >=65 years | Participants | 5 |
| Sex: Female, Male: Female | Participants | 6 |
| Sex: Female, Male: Male | Participants | 3 |
| Region of Enrollment: United States | participants | 9 |
6. Primary Endpoint
The registry lists the primary outcome as Objective Response Rate as Measured by RECIST Criteria, measured over Up to 2 years.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is objective response rate measured by RECIST criteria, with assessment described over a timeframe of up to 2 years. Objective response is used in cancer studies to summarize whether tumors meet specified criteria for measurable shrinkage or disappearance. As a general statistical concept, a response rate is based on the number of participants meeting the response definition relative to the relevant analysis population.
The registry describes the primary outcome using a participant count, but it does not report that count, the corresponding response rate, or an uncertainty interval. Thus, the endpoint’s intended meaning is clear, while its observed result is not available in the registry record. The record also does not specify the analysis population, how participants without an evaluable assessment were handled, or whether response confirmation was required. Those details matter because choices about assessment and missing observations can change how a response summary should be interpreted.
RECIST provides a standardized framework for assessing tumor response, which can support consistent outcome definitions across studies. It does not, by itself, make a single-group result comparative. Without a control group and the reported response result, the endpoint cannot establish whether the regimen changed response outcomes relative to another option.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes that this completed phase II study enrolled 10 patients in a single treatment group and selected objective response by RECIST criteria as its primary outcome. It does not report the observed response count, a response rate, a confidence interval, or a statistical test for that endpoint. Consequently, the primary efficacy result cannot be estimated from the registry information. The absence of a posted result is not evidence that the response count was zero; the value is not reported in the registry record.
Precision is also unavailable. In general, a confidence interval describes the range of estimates compatible with the observed data under the statistical method used. For a response proportion, precision depends on the number of participants contributing to the analysis and the observed responses. Since the registry does not report the response count, analysis population, or interval, readers cannot assess how uncertain an estimated response might have been. Enrollment alone does not supply that information.
The study’s single-group, non-randomized structure places a further limit on interpretation. Outcomes among treated participants could be described if reported, but there is no concurrent comparison group to separate treatment-associated outcomes from other factors. The design therefore cannot support a controlled estimate of comparative benefit or harm. Open-label conduct may also matter for outcome assessment and reporting, although the extent of any effect is not reported in the registry record.
The record lists time to progression and overall survival as secondary outcomes, but does not report estimates or analyses for them. It also lists safety information, including serious adverse event summaries. Those safety entries describe events recorded for the study group; they do not provide a comparative safety estimate. The registry record does not report the detailed follow-up or analysis methods needed to interpret time-to-event outcomes, such as censoring rules or the analysis population.
Planning illustrations based on an observed effect, when presented, are not observed power and do not replace the study’s actual outcome analysis. The registry record does not report its own sample-size justification or statistical plan. In the absence of endpoint results and analysis details, the defensible conclusion is limited: the study evaluated the specified combination in a small, single-group phase II setting, but the posted registry information does not establish the observed response or its precision.
9. Statistical Methods Explained
Statistical methods determine how outcomes are defined, which participants contribute to an analysis, and how uncertainty is quantified. For this study, the registry identifies a binary primary outcome measured as a participant count: objective response by RECIST criteria. It does not provide a statistical analysis plan or an analysis entry. The interpretation of an outcome therefore cannot be supplemented with undocumented assumptions about the model, adjustment, or decision criteria.
What does an objective response measure?
As a general concept, a binary endpoint classifies each participant according to whether a defined event occurred. For objective response, the event is meeting the response criteria. The result is often expressed as a count and as a proportion of an analysis population. The count answers how many participants met the definition; the proportion places that count in relation to the population being analyzed. Neither can be recovered from enrollment alone. The registry record gives no response count, proportion, or uncertainty interval.
RECIST is a standardized approach to classifying tumor response. Standard definitions help researchers make outcome assessments more comparable, but the particular assessment schedule, confirmation rules, and handling of unevaluable scans can affect a study’s result. These details are not reported in the registry record. The listed timeframe, up to 2 years, indicates the stated period for the primary outcome; it does not supply the assessment details or observed outcome.
Why does the single-group design matter?
In a randomized comparison, random allocation is intended to make treatment groups comparable on average, allowing a between-group contrast to estimate a treatment effect under the design’s assumptions. This study was non-randomized and had a single treatment group. There is no internal control group against which to calculate a comparative effect. Even if an outcome count were available, it would describe the treated group rather than establish what would have happened under another treatment or no study treatment.
Open-label means treatment assignment was not masked. In general, knowledge of treatment can affect behavior, reporting, or outcome assessment, depending on the endpoint and procedures. The registry does not report how response assessments were conducted or whether independent review was used. No particular direction or size of possible bias can be inferred from the record.
What can uncertainty measures tell readers?
For a binary outcome, a confidence interval communicates uncertainty around an estimated response proportion. A narrow interval indicates greater precision under the chosen method, while a wide interval indicates less precision. With no reported response estimate or interval, readers cannot judge that precision. The enrollment figure does not reveal how many participants were evaluable for response, and the relevant analysis population is not reported in the registry record.
For time-to-event outcomes such as time to progression or overall survival, general methods account for the timing of events and for participants whose event time is not observed during follow-up. The registry names these secondary outcomes but does not report estimates, event counts, follow-up details, censoring rules, or analysis methods. It is therefore not possible to interpret their statistical results from the record.
How should planning illustrations be read?
General sample-size calculations can illustrate the number of participants per arm needed under specified assumptions, such as a significance level, allocation pattern, statistical approximation, and effect size to detect. The stated planning assumptions use a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and fractions of an observed effect. Such values are planning illustrations, not the trial’s observed power. The registry does not report that these assumptions were the trial’s original design plan, nor does it report its own sample-size justification. Any illustration based on an observed effect depends on the estimate used and should not be mistaken for evidence that a future study will reproduce that effect.
Multiplicity arises when multiple outcomes or statistical tests are considered. Without an analysis plan, it is not known whether or how multiplicity was addressed. The registry record does not report a statistical analysis plan, adjustments for multiple testing, or interim analyses. These omissions limit the reader’s ability to distinguish prespecified analyses from exploratory ones or to assess the overall interpretation of any tests. Since the primary result itself is not reported, no claim about statistical significance can be made from the record.
10. Multiplicity, Missing Data and Analysis Populations
The registry names objective response rate as the primary outcome and lists time to progression and overall survival as secondary outcomes. It does not report results for these endpoints or a statistical analysis plan. The record therefore does not show which analyses were prespecified, whether other outcomes were examined, or whether any adjustment for multiple testing was planned or applied. When several outcomes or tests are considered, multiplicity can increase the chance of a seemingly notable result arising by chance. Whether that issue affected this study cannot be determined from the registry record.
Missing-data methods are also not reported. The record does not say how participants without an evaluable response assessment were handled, whether follow-up was complete, or how missing observations were treated for the time-to-event outcomes. These choices matter because the analysis population and missingness assumptions can influence estimates and uncertainty. No specific missing-data approach should be inferred.
The registry reports enrollment of 10, but does not identify the analysis population for each outcome. It also does not report a detailed participant flow or explain whether all enrolled participants contributed to each analysis. The number enrolled should not be assumed to equal the number analyzed.
No analysis entries are listed in the registry record. This does not establish that no analyses were performed; it means their methods and results are not reported in the record. Interim analyses, stopping rules, and the rationale for the planned enrollment are likewise not reported in the registry record. Together, these gaps restrict assessment of multiplicity, missingness, and analysis-population choices.
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 |
|---|---|---|---|
| Docetaxel and Flavopiridol | 10 | 10 | 100.0% |
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 |
|---|---|
| Docetaxel and Flavopiridol | 9 of 9 |
Most frequent serious adverse event terms
| Event term | Organ system | Docetaxel and Flavopiridol |
|---|---|---|
| Diarrhea | Gastrointestinal disorders | 4 of 10 |
| White blood cell decreased | Investigations | 4 of 10 |
| Lymphocyte count decreased | Investigations | 4 of 10 |
| Neutrophil count decreased | Investigations | 4 of 10 |
| Fatigue | General disorders | 3 of 10 |
| Thrombosis | Vascular disorders | 3 of 10 |
| Death not associated w/ CTCAE term-Disease Progression NOS | General disorders | 2 of 10 |
| Dehydration | Metabolism and nutrition disorders | 2 of 10 |
| Hyperglycemia | Metabolism and nutrition disorders | 2 of 10 |
| Anemia | Blood and lymphatic system disorders | 2 of 10 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Docetaxel and Flavopiridol |
|---|---|---|
| Hyperglycemia | Metabolism and nutrition disorders | 9 of 9 |
| White blood cell decreased | Investigations | 6 of 9 |
| Hypoalbuminemia | Metabolism and nutrition disorders | 5 of 9 |
| Fatigue | General disorders | 5 of 9 |
| Lymphocyte count decreased | Investigations | 5 of 9 |
| Diarrhea | Gastrointestinal disorders | 4 of 9 |
| Neutrophil count decreased | Investigations | 4 of 9 |
| Hypoglycemia | Metabolism and nutrition disorders | 3 of 9 |
| Hemoglobin | Blood and lymphatic system disorders | 3 of 9 |
| Hypophosphatemia | Metabolism and nutrition disorders | 3 of 9 |
Serious events with the highest arm-level rate: diarrhea (40.0%), white blood cell decreased (40.0%), lymphocyte count decreased (40.0%), neutrophil count decreased (40.0%), fatigue (30.0%).
The safety record lists a Docetaxel and Flavopiridol group, with 10 at risk and 10 affected for serious adverse events. For other adverse events, it lists 9 at risk and 9 affected. These are registry counts for the categories described; the record does not explain the difference in the at-risk groups or provide further analysis-population details. Deaths are not reported in the registry record.
The listed serious adverse event terms include diarrhea, white blood cell decreased, lymphocyte count decreased, and neutrophil count decreased, each reported as 40.0%. Fatigue and thrombosis are each reported as 30.0%. These percentages should be read as the registry’s reported values, not as comparative estimates. The record does not provide a control group, so it cannot show whether the listed events were more or less frequent than with another treatment.
Serious adverse events are not interchangeable with all adverse events or with treatment-related events. The record does not provide enough detail to determine attribution, timing, duration, severity grading, or whether a participant experienced more than one listed term. The percentages should therefore be interpreted alongside the limited safety population information rather than as a complete account of treatment tolerability.
12. What the Result Does, and Does Not, Mean
The record documents a completed, open-label, non-randomized phase II study of docetaxel followed by alvocidib (flavopiridol) in refractory metastatic pancreatic cancer. It identifies the intended primary outcome, objective response by RECIST criteria, and gives a timeframe of up to 2 years. It also identifies time to progression and overall survival as secondary outcomes and includes safety summaries.
What the record does not establish is the observed response result. The primary response count and rate are not reported in the registry record, nor are uncertainty intervals or analysis details. Therefore, the record cannot show how frequently objective responses occurred or how precisely a response estimate was measured. The missing result should not be interpreted as a negative result or as no response.
The design also does not estimate comparative effectiveness. Because the study used a single treatment group without randomization or a comparator, any reported outcome would describe that group rather than isolate the contribution of the combination relative to another treatment. The registry’s safety entries likewise do not provide a controlled comparison. They identify reported event terms and percentages but do not establish that the regimen caused those events or that its safety differs from another option.
In general, a study can be informative about feasibility, outcome measurement, and observed events while still leaving comparative questions unanswered. The record’s phase II label and enrollment figure do not themselves establish efficacy, precision, or adequacy of design. The registry also does not report the statistical plan, missing-data handling, or details of the analysis populations. These limitations mean that conclusions should remain confined to the study’s design and the information actually recorded, without treating absent efficacy results as proof in either direction.
13. Why This Trial Matters Statistically
This study matters statistically because it illustrates the difference between identifying a clinical question and having the results needed to answer it. The record specifies an objective response endpoint and a treatment regimen, but does not report the response count or estimate. A clearly named endpoint is not itself an outcome finding. Without the result and a measure of uncertainty, readers cannot assess either the observed response or its precision.
It also illustrates the limits of a single-group design. Such a study can record outcomes among patients who received the regimen, but it does not provide a concurrent comparison that can distinguish treatment effects from other explanations. This is especially important when interpreting outcomes in a setting with refractory metastatic disease, where the registry’s listed population and treatment context do not by themselves define what would have occurred under an alternative.
The safety summaries add another useful statistical distinction: reporting event terms and percentages is not the same as demonstrating comparative risk or causation. The registry does not report a control group, detailed attribution, or event-level analysis. Readers need those distinctions to avoid drawing stronger conclusions than the design and data support.
Finally, the record highlights the role of transparent analysis reporting. The analysis plan, handling of missing outcomes, and approach to multiple endpoints are not reported in the registry record. Without these details, even a posted estimate would be harder to interpret fully. Statistical relevance lies in recognizing the boundary between study description and evidence of a comparative treatment effect.
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 specific to this trial record is that the primary outcome result is not reported. Although objective response by RECIST is identified as the primary endpoint, the response count, rate, and uncertainty are absent. Results for the secondary outcomes of time to progression and overall survival are also not reported in the registry record.
The single-group, non-randomized design has no concurrent comparator. It cannot support a like-for-like estimate against another treatment, and any group outcome would be vulnerable to influences that cannot be separated from treatment. Open-label conduct is stated, but the record does not describe response review procedures or safeguards against assessment bias.
Enrollment is listed as 10, but the analysis populations, participant flow, and evaluability for the outcomes are not reported. The registry also does not specify missing-data handling, response confirmation procedures, time-to-event methods, or follow-up completeness. These omissions limit assessment of both outcome validity and precision.
The statistical analysis plan, sample-size justification, interim analyses, and multiplicity approach are not reported in the registry record. The safety information gives aggregate group counts and selected serious adverse event terms, but does not report attribution, event timing, or the detail needed to make a comparative safety assessment. These limitations are specific to what the registry record documents and do not establish what analyses may have been conducted elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Docetaxel and Flavopiridol in Treating Patients With Refractory Metastatic Pancreatic Cancer — NCT00331682.
- Registry record last updated 2014-05-28; status last verified 2013-11.
- Results first posted 2014-01-10.
- 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
NCT00331682 is a completed, open-label, non-randomized phase II study sponsored by the National Cancer Institute. It lists enrollment of 10 and a single treatment group receiving docetaxel followed by flavopiridol (alvocidib) for refractory metastatic pancreatic cancer. The listed primary outcome is objective response rate by RECIST criteria, with a timeframe of up to 2 years; time to progression and overall survival are listed as secondary outcomes.
The registry record does not report the primary response result, secondary outcome estimates, or a statistical analysis plan. Safety entries list serious adverse event counts and selected event terms with percentages, but no comparative group is available. The record therefore describes the study design and selected safety information without providing enough efficacy results to assess response or its precision.