Docetaxel and Carboplatin in Treating Patients With Relapsed Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cavity Cancer

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

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel 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 II trial is studying how well giving docetaxel together with carboplatin works in treating patients with relapsed stage III or stage IV ovarian epithelial or primary peritoneal cavity cancer.

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

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Docetaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer

• Stage III or IV disease

• No borderline tumors

• Measurable or evaluable disease

• Measurable disease, defined as evidence of disease by physical examination or radiographic evaluation

• Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests performed ≥ 1 week apart)

• In first relapse

• Platinum-sensitive disease, defined as initial relapse > 6 months after completion of a platinum-based regimen

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• Platelet count ≥ 100,000/mm^3

• Absolute neutrophil count ≥ 1,500/mm^3

Hepatic

• Bilirubin normal

• Meets 1 of the following criteria:

• SGOT and/or SGPT ≤ 1.5 times upper limit of normal (ULN) AND alkaline phosphatase (AP) ≤ 2.5 times ULN

• SGOT and/or SGPT ≤ 5.0 times ULN AND AP normal

Renal

• Creatinine ≤ 2.0 mg/dL

• Creatinine clearance > 50 mL/min

Cardiovascular

• LVEF ≥ 50%

• No poorly controlled arrhythmia

• No unstable coronary artery disease or myocardial infarction within the past year

Other

• HIV negative

• No pre-existing peripheral neuropathy > grade 2

• No history of allergy to study drugs

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

• At least 3 weeks since prior chemotherapy and recovered

Endocrine therapy

• Not specified

Radiotherapy

• At least 3 weeks since prior radiotherapy and recovered

Surgery

• Recovered from recent prior surgery

Other

• No concurrent myelosuppressive therapy