Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Completed · Phase 2
Conditions studied: 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
In brief
This phase II trial is studying how well giving cisplatin together with flavopiridol works in treating patients with advanced ovarian epithelial cancer or primary peritoneal cancer. Drugs used in chemotherapy, such as cisplatin and flavopiridol, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
Key facts
- Study ID
- NCT00083122
- Run by
- National Cancer Institute (NCI)
- People needed
- 45
- Starts
- 2004-04-01
- Expected to finish
- 2012-05-01
- Last updated by the study team
- 2014-05-21
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed ovarian epithelial or primary peritoneal cancer:
- Advanced disease
- Meets at least 1 of the following criteria:
- Measurable disease;
- Evaluable disease plus CA 125 >= 2 times post-treatment nadir
- Treated with 1, and only 1, prior platin-containing chemotherapy regimen (e.g., paclitaxel or carboplatin-based) for ovarian epithelial or primary peritoneal cancer
- Prior treatment with the same regimen at first relapse allowed;
- No more than 3 total chemotherapy regimens allowed provided exactly 1 has been platin-containing;
- Must also have platin-resistant disease as defined for Group 1;
- Rechallenge with a single regimen upon progression after a hiatus from therapy counts as a single regimen
- Group 1, meeting 1 of the following criteria:
- Patients who relapse during or < 6 months after completion of post-debulking chemotherapy;
- "Platinum sensitive" patients in second relapse after having been treated/rechallenged with their initial regimen upon first relapse
- Group 2 (Closed to accrual as of 3/10/06):
- Patients who relapse >= 6 months after completion of post-debulking chemotherapy and are not retreated with the same or a different regimen
- No CNS metastases
- Performance status:
- ECOG 0-2
- Hematopoietic:
- Absolute neutrophil count >= 1,500/mm3;
- Platelet count >= 100,000/mm3;
- Hemoglobin >= 10 g/dL (Note: May be supported with transfusion, epoetin alfa, or darbepoetin alfa)
- Hepatic:
- AST =< 2.5 times upper limit of normal (ULN);
- Alkaline phosphatase =< 2.5 times ULN;
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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