Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Condition: 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
MeSH terms: Carcinoma, Ovarian Epithelial; Peritoneal Neoplasms; Recurrence
Intervention: cisplatin; alvocidib; cisplatin/flavopiridol
Intervention description: Given IV; Given IV; Given IV
Intervention MeSH terms: Cisplatin; Alvocidib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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;

               -  "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