Trial · NCT00191646
An Ovarian, Primary Peritoneal or Fallopian Tube Cancer Study for Patients That Have Not Received Prior Chemotherapy
NCT00191646, Phase 3, Completed, Eli Lilly and Company; results first posted 2010-09-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Ovarian, Primary Peritoneal or Fallopian Tube Cancer Study for Patients That Have Not Received Prior Chemotherapy. Trials, record NCT00191646. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00191646
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Ovarian, Primary Peritoneal or Fallopian Tube Cancer Study for Patients That Have Not Received Prior Chemotherapy
- NCT number
- NCT00191646
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 919 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Genital Neoplasms, Female, Fallopian Tube Neoplasms, Ovarian Neoplasms, Pelvic Neoplasms, Peritoneal Neoplasms
- Interventions
- Gemcitabine, Paclitaxel, Carboplatin
- First posted
- 2005-09-19
- Last updated
- 2011-03-04
- Results first posted
- 2010-09-09
- Limitations and caveats
Trial was designed with overall survival as primary endpoint. Enrollment was slower than expected. After 4 years, 919 patients were randomized and in August 2006, protocol was amended: primary endpoint was changed to progression free survival (PFS).
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Baseline to measured progressive disease or death up to 82 months | Progression free survival was defined as the duration from the date of randomization to the first date of documented disease progression or death from any cause. Tumor assessments were performed every three 21-day cycles during induction and crossover. Progression free survival was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies. |
| Secondary | Proportion of Participants With Response (Response Rate) | Baseline to measured progressive disease up to 82 months | Response rate (RR) = proportion of participants with best overall Complete Response (CR: disappearance of all target lesions \[TL\]) or Partial Response (PR: 30% decrease in sum of longest diameter of TL). Induction therapy RR = number of participants with CR or PR during induction divided by number of participants with measurable disease at baseline (TL measurement during screening). Crossover therapy RR = number of participants with CR or PR during crossover divided by number of participants with measurable disease at baseline (latest TL measurement by first dose date of crossover therapy). |
| Secondary | Time to Treatment Failure | Baseline to stopping treatment up to 82 months | Time to treatment failure was defined as the duration from date of randomization to the date of the first of the following events: early discontinuation of study therapy; progression of disease, or death due to any cause. Time to treatment failure will be censored at the date of the last follow-up visit for participants who did not discontinue early, who are still alive, and who have not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies. |
| Secondary | Overall Survival | Baseline to death from any cause up to 82 months | Overall survival is defined as the duration from baseline to death. For participants who are still alive at the data cut-off date, survival will be censored at the last contact date. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | Baseline to measured progressive disease or death up to 82 months | Intent to treat (ITT) population, which includes all randomized participants. 3 participants in the Gemcitabine/Carboplatin treatment sequence were excluded due to missing data, and 1 participant in the Paclitaxel/Carboplatin treatment sequence was excluded for missing data. G/C Arm: 292 events, 122 censored. P/C Arm: 279 events, 134 censored. | Months | MEDIAN |
| SECONDARY | Proportion of Participants With Response (Response Rate) | Baseline to measured progressive disease up to 82 months | All ITT participants with measurable disease at baseline (screening) for induction period; all ITT participants who crossed over to single agent therapy and had measurable disease before or at crossover for crossover period. Participants in consolidation therapy achieved CR during induction therapy and were not included in analysis. | proportion of responders | MEAN |
| SECONDARY | Time to Treatment Failure | Baseline to stopping treatment up to 82 months | Intent to treat (ITT) population, which includes all randomized participants. 3 participants in the Gemcitabine/Carboplatin treatment sequence were excluded due to missing data, and 1 participant in the Paclitaxel/Carboplatin treatment sequence was excluded for missing data. G/C Arm: 336 events, 78 censored. P/C Arm: 330 events, 83 censored. | months | MEDIAN |
| SECONDARY | Overall Survival | Baseline to death from any cause up to 82 months | Intent to treat (ITT) population, which includes all randomized participants. 3 participants in the Gemcitabine/Carboplatin treatment sequence were excluded due to missing data, and 1 participant in the Paclitaxel/Carboplatin treatment sequence was excluded for missing data. G/C Arm: 194 events, 220 censored. P/C Arm: 159 events, 254 censored. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | Gemcitabine/Carboplatin | 20.0 | 95% Confidence Interval 17.9 to 22.2 | Months | |
| Progression Free Survival (PFS) | Paclitaxel/Carboplatin | 22.2 | 95% Confidence Interval 19.0 to 25.7 | Months | |
| Proportion of Participants With Response (Response Rate) | Gemcitabine/Carboplatin (Induction) | 0.676 | 95% Confidence Interval 0.638 to 0.798 | proportion of responders | |
| Proportion of Participants With Response (Response Rate) | Paclitaxel/Carboplatin (Induction) | 0.711 | 95% Confidence Interval 0.651 to 0.822 | proportion of responders | |
| Proportion of Participants With Response (Response Rate) | Gemcitabine (Crossover) | 0.357 | 95% Confidence Interval 0.194 to 0.576 | proportion of responders | |
| Proportion of Participants With Response (Response Rate) | Paclitaxel (Crossover) | 0.303 | 95% Confidence Interval 0.161 to 0.500 | proportion of responders | |
| Time to Treatment Failure | Gemcitabine/Carboplatin | 13.0 | 95% Confidence Interval 11.7 to 15.1 | months | |
| Time to Treatment Failure | Paclitaxel/Carboplatin | 13.1 | 95% Confidence Interval 11.4 to 14.3 | months | |
| Overall Survival | Gemcitabine/Carboplatin | 43.8 | 95% Confidence Interval 38.8 to 48.4 | months | |
| Overall Survival | Paclitaxel/Carboplatin | 57.3 | 95% Confidence Interval 48.5 to 64.0 | months |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gemcitabine/Carboplatin | 417 | |
| Overall Study | STARTED | Paclitaxel/Carboplatin | 414 | |
| Overall Study | Received Induction Therapy | Gemcitabine/Carboplatin | 411 | |
| Overall Study | Received Induction Therapy | Paclitaxel/Carboplatin | 409 | |
| Overall Study | Received Consolidation Therapy | Gemcitabine/Carboplatin | 169 | |
| Overall Study | Received Consolidation Therapy | Paclitaxel/Carboplatin | 183 | |
| Overall Study | Received Crossover Therapy | Gemcitabine/Carboplatin | 77 | |
| Overall Study | Received Crossover Therapy | Paclitaxel/Carboplatin | 78 | |
| Overall Study | COMPLETED | Gemcitabine/Carboplatin | 246 | |
| Overall Study | COMPLETED | Paclitaxel/Carboplatin | 261 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,470
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymphopenia | Blood and lymphatic system disorders | Gemcitabine/Carboplatin Induction | 9 | 412 | 25 |
| other | Lymphopenia | Blood and lymphatic system disorders | Paclitaxel/Carboplatin Induction | 10 | 408 | 25 |
| other | Lymphopenia | Blood and lymphatic system disorders | Consolidation (Gemcitabine to Paclitaxel) | 2 | 169 | 4 |
| other | Lymphopenia | Blood and lymphatic system disorders | Consolidation (Paclitaxel to Paclitaxel) | 4 | 183 | 9 |
| other | Lymphopenia | Blood and lymphatic system disorders | Crossover (Paclitaxel to Gemcitabine) | 4 | 78 | 10 |
| other | Lymphopenia | Blood and lymphatic system disorders | Crossover (Gemcitabine to Paclitaxel) | 1 | 77 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Gemcitabine/Carboplatin Induction | 22 | 412 | 68 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Paclitaxel/Carboplatin Induction | 8 | 408 | 12 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Consolidation (Gemcitabine to Paclitaxel) | 1 | 169 | 4 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Consolidation (Paclitaxel to Paclitaxel) | 1 | 183 | 7 |
1 to 10 of 1,470Source ClinicalTrials.gov
See all 1,470 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gemcitabine/Carboplatin Induction | ||
| Total, all-cause mortality | Paclitaxel/Carboplatin Induction | ||
| Total, all-cause mortality | Consolidation (Gemcitabine to Paclitaxel) | ||
| Total, all-cause mortality | Consolidation (Paclitaxel to Paclitaxel) | ||
| Total, all-cause mortality | Crossover (Paclitaxel to Gemcitabine) | ||
| Total, all-cause mortality | Crossover (Gemcitabine to Paclitaxel) | ||
| Total, other adverse events | Gemcitabine/Carboplatin Induction | 404 | 412 |
| Total, other adverse events | Paclitaxel/Carboplatin Induction | 394 | 408 |
| Total, other adverse events | Consolidation (Gemcitabine to Paclitaxel) | 157 | 169 |
| Total, other adverse events | Consolidation (Paclitaxel to Paclitaxel) | 170 | 183 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00191646
GET https://conductscience.org/api/trials/v1/NCT00191646/events?page=2