Phase II CT-2103/Carboplatin in Ovarian Cancer

Inclusion Criteria

• •Histologically-confirmed stage III or IV ovarian carcinoma or primary peritoneal cancer patients who have had appropriate debulking surgery for ovarian or peritoneal carcinoma.
• •Patients must be recovered from initial surgery and must enter this study no later than 12 weeks after such surgery.
• •ECOG performance score of 0, 1, or 2.
• •absolute neutrophil count (ANC) at least 1,500/µL.
• •platelet at least 100,000/µL.
• •hemoglobin at least 10 g/dL.
• •creatinine no greater than 1.5 times the upper limit of normal (ULN).
• •bilirubin no greater than 1.5 x ULN (if liver metastases are not present, SGOT and SGPT no greater than 2.5 x ULN, if liver metastases are present, SGOT and SGPT may be no greater than 5 x ULN.
• •Alkaline phosphatase no greater than 2.5 x ULN.
• •Exclusion:
• •Current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas)
• •Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors or carcinosarcomas, metastatic carcinomas from sites other than the ovary, and low malignant potential tumors including so called micropapillary serous carcinomas.
• •Synchronous primary endometrial cancer or history of primary endometrial cancer.
• •Evidence of any other invasive malignancies present within the 3 years before this study, with the exception of non-melanoma skin cancer and other specific malignancies as noted above.
• •Any prior treatment, other than initial debulking surgery, for the cancer being treated in this study.
• •Patients may have received prior adjuvant chemotherapy for localized breast cancer, if the therapy was completed at least 3 years before registration in this study and if the patient remains free of recurrent or metastatic disease.
• •Prior radiotherapy to any portion of the abdominal cavity or pelvis.
• •Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, if it was completed at least 3 years before registration in this study and if the patient remains free of recurrent or metastatic disease.
• •Administration of other investigational drugs within 26 weeks before the first treatment in this study. Toxic manifestations of previous treatments (except alopecia) must have been stable for 4 weeks.
• •Presence of active hepatitis, either acute or chronic.
• •Presence of active infection requiring antibiotic or antiviral therapy.
• •Pregnant women or nursing mothers.