Paclitaxel-Loaded Polymeric Micelle and Carboplatin as First-Line Therapy in Treating Patients With Advanced Ovarian Cancer

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

Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel-loaded polymeric micelle and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel-loaded polymeric micelle and carboplatin and to see how well they work as first-line therapy in treating patients with advanced ovarian cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed advanced ovarian cancer

• Measurable disease by RECIST criteria

• No prior or concurrent CNS metastasis

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy > 6 months

• Clinically acceptable blood, kidney, and spleen function

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No preexisting sensory or motor neuropathy ≥ grade 1

• No other malignancies within the past 5 years

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy for ovarian cancer

• No prior immunotherapy or hormonal therapy for ovarian cancer

• No prior radiotherapy to the pelvis or abdominal cavity

• More than 2 weeks since prior major surgery other than debulking surgery