Trial · NCT00083122
Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer
NCT00083122, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-05-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer. Trials, record NCT00083122. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00083122
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer
- NCT number
- NCT00083122
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer, Stage IIIA Ovarian Epithelial Cancer, Stage IIIA Primary Peritoneal Cavity Cancer, Stage IIIB Ovarian Epithelial Cancer, Stage IIIB Primary Peritoneal Cavity Cancer, Stage IIIC Ovarian Epithelial Cancer, Stage IIIC Primary Peritoneal Cavity Cancer, Stage IV Ovarian Epithelial Cancer, Stage IV Primary Peritoneal Cavity Cancer
- Interventions
- cisplatin, alvocidib, cisplatin/flavopiridol
- First posted
- 2004-05-17
- Last updated
- 2014-05-21
- Results first posted
- 2013-05-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR) | 24 weeks | A Complete Response (CR) is defined as the disappearance of all target lesions and normalization of tumor biomarkers. A Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4-6 weeks apart. |
| Secondary | Overall Survival | Time from registration to date of last follow-up or death due to any cause, assessed up to 3 years | Will be estimated using the method of Kaplan-Meier. |
| Secondary | Time to Progression | Time from registration to the date of progression or last follow-up, assessed up to 3 years | Time to progression will be estimated using the method of Kaplan-Meier. Progression is defined as having at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR) | 24 weeks | All 45 participants were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | Overall Survival | Time from registration to date of last follow-up or death due to any cause, assessed up to 3 years | All 40 participants in Group 1 were analyzed for this primary endpoint. However, due to the low accrual and early group 2 closure, Group 2 was not statistically evaluated for this endpoint. | months | MEDIAN |
| SECONDARY | Time to Progression | Time from registration to the date of progression or last follow-up, assessed up to 3 years | All 40 participants from Group 1 were analyzed. However, due to slow accrual and early closure, Group 2 was not statistically analyzed for this endpoint. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR) | Group 1 (Platin Resistant) | Complete Response (CR) | 2.5 | Percentage of Participants | |
| Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR) | Group 2 (Platin Sensitive) | Complete Response (CR) | 0 | Percentage of Participants | |
| Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR) | Group 1 (Platin Resistant) | Partial Response (PR) | 15 | Percentage of Participants | |
| Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR) | Group 2 (Platin Sensitive) | Partial Response (PR) | 40 | Percentage of Participants | |
| Overall Survival | Group 1 (Platin Resistant) | 17.5 | 95% Confidence Interval 10.8 to 24.5 | months | |
| Time to Progression | Group 1 (Platin Resistant) | 4.3 | 95% Confidence Interval 2.89 to 5.81 | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 (Platin Resistant) | 40 | |
| Overall Study | STARTED | Group 2 (Platin Sensitive) | 5 | |
| Overall Study | COMPLETED | Group 1 (Platin Resistant) | 40 | |
| Overall Study | COMPLETED | Group 2 (Platin Sensitive) | 5 | |
| Overall Study | NOT COMPLETED | Group 1 (Platin Resistant) | 0 | |
| Overall Study | NOT COMPLETED | Group 2 (Platin Sensitive) | 0 |
Source ClinicalTrials.gov
Adverse events92
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 | Hemoglobin decreased | Blood and lymphatic system disorders | Group 1 and Group 2 Combined | 42 | 45 | 179 |
| other | Palpitations | Cardiac disorders | Group 1 and Group 2 Combined | 2 | 45 | 2 |
| other | Hearing impaired | Ear and labyrinth disorders | Group 1 and Group 2 Combined | 2 | 45 | 3 |
| other | Hearing test abnormal | Ear and labyrinth disorders | Group 1 and Group 2 Combined | 1 | 45 | 1 |
| other | Tinnitus | Ear and labyrinth disorders | Group 1 and Group 2 Combined | 3 | 45 | 15 |
| other | Abdominal pain | Gastrointestinal disorders | Group 1 and Group 2 Combined | 1 | 45 | 1 |
| other | Colitis | Gastrointestinal disorders | Group 1 and Group 2 Combined | 1 | 45 | 1 |
| other | Constipation | Gastrointestinal disorders | Group 1 and Group 2 Combined | 3 | 45 | 7 |
| other | Diarrhea | Gastrointestinal disorders | Group 1 and Group 2 Combined | 31 | 45 | 123 |
| other | Dry mouth | Gastrointestinal disorders | Group 1 and Group 2 Combined | 1 | 45 | 2 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 and Group 2 Combined | ||
| Total, other adverse events | Group 1 and Group 2 Combined | 45 | 45 |
| Total, serious adverse events | Group 1 and Group 2 Combined | 23 | 45 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22664059 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT00083122
GET https://conductscience.org/api/trials/v1/NCT00083122/events?page=2