Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer

• Status: Completed
• Trial end date: 2003-03-01
• 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.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating women who have ovarian epithelial cancer or primary peritoneal cancer that has not responded to previous treatment.

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

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Treatments: Docetaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial or primary peritoneal serous cancer that is resistant to platinum therapy

• Platinum resistance as defined by one of the following:

• Relapse within 6 months of platinum based chemotherapy

• Residual disease after completion of platinum based chemotherapy

• Disease progression while receiving platinum based chemotherapy

• Marker only relapse (CA-125 elevation) and measurable disease

• Bidimensionally measurable disease on exam or CT scan

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Female

Performance status:

• ECOG 0-2

Life expectancy:

• Greater than 2 months

Hematopoietic:

• WBC at least 3,000/mm3

• Absolute neutrophil count at least 1,500/mm3

• Platelet count at least 100,000/mm3

Hepatic:

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

• SGPT or SGOT no greater than 1.5 times ULN

• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• Acceptable cardiac exam

• No active cardiac ischemia

Pulmonary:

• Acceptable pulmonary exam

• No active pulmonary infection or compromise

Other:

• Not pregnant or nursing

• No severe peripheral neuropathy (grade 2 or greater)

• No other significant psychiatric or medical conditions that would interfere with compliance

• No other malignancies within the past 3 years, except:

• Limited basal or squamous cell skin cancer

• Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior cytokine therapy

Chemotherapy:

• See Disease Characteristics

• At least 3 weeks since prior chemotherapy for ovarian epithelial or peritoneal serous cancer

• Prior paclitaxel allowed

• No prior docetaxel

• At least 3 years since prior chemotherapy for other disease

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior pelvic radiotherapy

Surgery:

• Not specified