Ovarian Cancer Clinical Trial
Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer
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.
Full Description
OBJECTIVES:
Determine the activity of docetaxel in women with platinum resistant, refractory ovarian epithelial or primary peritoneal serous cancer.
OUTLINE: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive a minimum of 6 courses of therapy, including 2 courses beyond CR.
PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 2 years.
Eligibility 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
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There is 1 Location for this study
Boston Massachusetts, 02215, United States
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