Phase 2
N=45
Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer
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
Bottom Line
View on ClinicalTrials.gov: NCT00083122 ↗Enrolled (actual)
45
Serious AEs
51.1%
Results posted
May 2013
Primary outcome: Primary: Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR) — 2.5; 0; 15; 40 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cisplatin (Drug); alvocidib (Drug); cisplatin/flavopiridol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR) |
2.5; 0; 15; 40 | — |
| SECONDARY Overall Survival |
17.5 | — |
| SECONDARY Time to Progression |
4.3 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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 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 = = grade 2
- No baseline diarrhea (>= 4 stools/day)
- No uncontrolled infection
- No other concurrent uncontrolled serious medical condition
- No concurrent routine colony-stimulating factors
Data sourced from ClinicalTrials.gov (NCT00083122). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.