Phase II CT-2103/Carboplatin in Ovarian Cancer

CT-2103/Carboplatin for Patients With Newly Diagnosed Stage III or IV Ovarian or Primary Peritoneal Cancer: A Phase 2 Study

The purpose of this study is to evaluate the safety and efficacy of CT-2103 (poly(L)glutamate-paclitaxel) in combination with carboplatin for the treatment of patients with Stage III or IV ovarian or primary peritoneal cancer.

CT-2103 is a pharmaceutical that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer. The objective of this trial is to evaluate the toxicity, estimate the response rate, progression-free survival and overall survival in patients with newly diagnosed stage III or IV ovarian or primary peritoneal carcinoma treated with CT-2103 in combination with carboplatin.

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.