Phase II CT-2103/Carboplatin in Ovarian Cancer

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CTI BioPharma
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel; Paclitaxel poliglumex

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.