Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00083122
• Date of registration: 14/05/2004
• Prospective Registration: No
• Primary sponsor: National Cancer Institute (NCI)
• Public title: Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer
• Scientific title: Phase II Trial of Flavopiridol and Cisplatin in Advanced Epithelial Ovarian and Primary Peritoneal Carcinomas
• Date of first enrolment: April 2004
• Target sample size: 45
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00083122
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Keith Bible
• Affiliation: Mayo Clinic

Key inclusion & exclusion 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;

- "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;

- Bilirubin =< 1.5 times ULN

- Renal:

- Creatinine =< 1.5 times ULN

- Cardiovascular:

- No cardiac arrhythmia;

- No cardiac failure

- Not pregnant or nursing

- Negative pregnancy test

- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)

- More than 3 weeks since prior radiotherapy

- Recovered from all prior therapy

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except non-melanoma skin cancer or
carcinoma in situ of the cervix

- No diabetes

- No peripheral neuropathy >= grade 2

- No baseline diarrhea (>= 4 stools/day)

- No uncontrolled infection

- No other concurrent uncontrolled serious medical condition

- No concurrent routine colony-stimulating factors



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Recurrent Ovarian Epithelial Cancer

Recurrent Primary Peritoneal Cavity Cancer

Stage IIIA Ovarian Epithelial Cancer

Stage IIIC Ovarian Epithelial Cancer

Stage IV Primary Peritoneal Cavity Cancer

Stage IIIB Ovarian Epithelial Cancer

Stage IIIB Primary Peritoneal Cavity Cancer

Stage IIIC Primary Peritoneal Cavity Cancer

Stage IV Ovarian Epithelial Cancer

Stage IIIA Primary Peritoneal Cavity Cancer

Intervention(s)

Drug: cisplatin/flavopiridol

Drug: alvocidib

Drug: cisplatin

Primary Outcome(s)

Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR) [Time Frame: 24 weeks]

Secondary Outcome(s)

Overall Survival [Time Frame: Time from registration to date of last follow-up or death due to any cause, assessed up to 3 years]

Time to Progression [Time Frame: Time from registration to the date of progression or last follow-up, assessed up to 3 years]

Secondary ID(s)

MC0261

5876

N01CM62205

CDR0000363562

NCI-2009-00029

P30CA015083

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/05/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00083122