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Home > "C" Clinical Trials Conditions > Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer  Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer
For Condition: peritoneal cavity cancer,recurrent ovarian epithelial cancer,stage 4 ovarian epithelial cancer
Status: Not yet recruiting
Sponsor(s): Mayo Clinic Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: 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. PURPOSE: Phase II trial to study the effectiveness of combining cisplatin with flavopiridol in treating patients who have advanced ovarian epithelial cancer or primaryperitoneal cancer.
Details: OBJECTIVES: - Determine the response rate, time to progression, and survival in patients with advanced ovarian epithelial or primary peritoneal cancer treated with cisplatin and flavopiridol. - Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are accrued to two separate groups: - 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 - Patients who relapse ≥ 6 months after completion of post-debulking chemotherapy and are not retreated with the same or a different regimen Patients receive cisplatin IV over 30 minutes and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for up to 3 years. PROJECTED ACCRUAL: A total of 38-79 patients (20-42 for group 1 and 18-37 for group 2) will be accrued for this study within 7-14 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - 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 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 CNS metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 - 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 Other - Not pregnant or nursing - Negative pregnancy test - 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 PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent routine colony-stimulating factors Chemotherapy - See Disease Characteristics - More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy - Not specified Radiotherapy - More than 3 weeks since prior radiotherapy Surgery - Not specified Other - Recovered from all prior therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KeithBible, Study Chair, Mayo Clinic Cancer Center
Additional Information:
Study ID Numbers: CDR0000363562; NCI-5876,MAYO-MC0261
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083122
Other Stage 4 Ovarian Epithelial Cancer Studies:
1. Carboplatin With or Without Liposomal Doxorubicin in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
2. Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer
3. Combination Chemotherapy Consisting of Gemcitabine And Topotecan in Treating Patients With Refractory or Recurrent Ovarian or Fallopian Tube Cancer
4. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer
5. Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Related Studies:
Other stage 4 ovarian epithelial cancer Clinical Trials
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Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer
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