Combination Chemotherapy in Treating Patients With Platinum-Resistant Recurrent Ovarian Cancer

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of dexamethasone plus paclitaxel and gemcitabine in treating patients with platinum-resistant recurrent ovarian cancer.

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

Details

• Lead Sponsor: University of Southern California
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Dexamethasone; Gemcitabine; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed recurrent ovarian epithelial cancer

• Platinum resistant disease defined as:

• Progression during the most recent platinum-based chemotherapy OR

• Relapse less than 6 months after platinum-based chemotherapy

• Measurable or evaluable disease

• Elevated CA-125 only allowed

• Positive cytology only not eligible

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• SWOG 0-2

Hematopoietic:

• Granulocyte count at least 1,500/mm^3

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

Hepatic:

• Bilirubin less than 2 times upper limit of normal (ULN)

• AST less than 3 times ULN

Renal:

• Creatinine no greater than 2 mg/dL

Neurologic:

• No peripheral neuropathy greater than grade 2

Other:

• No other serious medical illness or psychiatric conditions.

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent hematopoietic growth factors

Chemotherapy:

• See Disease Characteristics

• No prior gemcitabine

• No prior paclitaxel administered weekly

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• Recovered from acute toxic effects secondary to prior therapy