Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Trial of Weekly, Low-Dose Docetaxel (Taxotere) in Patients With Platinum-Resistant Epithelial Ovarian or Primary Peritoneal Serous Cancer

Conditions
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Ovarian Cancer, Peritoneal Cavity Cancer

Intervention / Treatment
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* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent ovarian epithelial cancer, peritoneal cavity cancer