Expired Study
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Boston, Massachusetts 02215


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00004081


Primary Contact:

Study Chair
Stephen A. Cannistra, MD
Beth Israel Deaconess Medical Center


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02215
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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