Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

This phase I trial is studying the side effects and best dose of polyglutamate paclitaxel when given together with carboplatin in treating patients with ovarian epithelial, peritoneal, or fallopian tube cancer. Drugs used in chemotherapy such as polyglutamate paclitaxel and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. Polyglutamate paclitaxel may be able to deliver the drug directly to tumor cells while leaving normal cells undamaged. Combining polyglutamate paclitaxel with carboplatin may kill more tumor cells.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel; Paclitaxel poliglumex

Criteria

Inclusion Criteria:

• Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube carcinoma

• Stage III or IV

• Optimal (no greater than 1 cm) or suboptimal residual disease after initial surgery

• The following histologic epithelial cell types are eligible:

• Serous adenocarcinoma

• Mucinous adenocarcinoma

• Clear cell adenocarcinoma

• Transitional cell carcinoma

• Adenocarcinoma not otherwise specified

• Endometrioid adenocarcinoma

• Undifferentiated carcinoma

• Mixed epithelial carcinoma

• Malignant Brenner tumor

• No epithelial tumors of low malignant potential (borderline tumors)

• Surgery performed within the past 12 weeks

• Performance status - GOG 0-2

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• No active bleeding

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• AST and ALT no greater than 2.5 times ULN (5 times ULN if liver metastasis)

• Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastasis)

• No acute hepatitis

• PT and PTT normal

• Creatinine no greater than 1.5 times ULN

• Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided cardiac status has been stable for the past 6 months

• No myocardial infarction within the past 6 months

• No unstable angina

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No neuropathy (sensory or motor) grade 2 or worse

• No other invasive malignancies within the past 5 years except nonmelanoma skin cancer or localized breast cancer

• No active infection requiring antibiotics

• No circumstances that would preclude study completion or follow-up

• More than 3 years since prior adjuvant chemotherapy for localized breast cancer (must be free of recurrent or metastatic disease)

• More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin (must be free of recurrent or metastatic disease)

• No prior radiotherapy to any portion of the abdominal cavity or pelvis

• No prior treatment, other than debulking surgery, for this cancer

• No prior treatment for another cancer that would contraindicate this protocol therapy

• No concurrent amifostine or other protective reagents