phase ii ct-2103/carboplatin in ovarian cancer

Conditions: Ovarian Neoplasm

Summary: 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.

Eligibility criteria:
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.

Keywords: ovarian cancer paclitaxel carboplatin