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Home > "D" Clinical Trials Conditions > Docetaxel Combined With Estramustine in Treating Patients With Metastatic Breast Cancer  Docetaxel Combined With Estramustine in Treating Patients With Metastatic Breast Cancer
Docetaxel Combined With Estramustine in Treating Patients With Metastatic Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer
Status: No longer recruiting
Sponsor(s): Herbert Irving Comprehensive Cancer Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of docetaxel combined with estramustine in treating women with metastatic breast cancer.
Details: OBJECTIVES: I. Determine the response rate, duration of response, duration of survival, and quality of life effects of docetaxel and estramustine combination in patients with metastatic breast cancer. PROTOCOL OUTLINE: Patients receive estramustine 3 times a day for 3 days. Docetaxel begins on day 3 after the a.m. dose of estramustine and is given as a 1 hour infusion intravenously. Courses repeat every 21 days. If disease responds or is stable, treatment continues at the highest tolerance percentage of prescribed dose until appearance of disease progression. If complete response is documented, an additional 2 courses are given. Patients should receive a minimum of 2 courses unless rapid progression or unacceptable toxicity occur. Patients are followed monthly. PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed metastatic breast cancer - Measurable or evaluable disease - Must be ineligible for other high priority national or institutional study - No visible metastases on brain CT or MRI (unless single lesion amenable to surgical resection) - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 4 weeks since prior chemotherapy (2 weeks if weekly regimen); Any number of prior chemotherapy regimens allowed - Endocrine therapy: Any number of prior hormonal therapy regimens allowed - Radiotherapy: At least 4 weeks since prior radiotherapy - Surgery: At least 1 week since prior surgery --Patient Characteristics-- - Age: Over 18 - Sex: Female - Menopausal status: Not specified - Performance status: ECOG 0-2 - Life expectancy: More than 2 months - Hematopoietic: WBC greater than 3,000/mm3; Platelet count greater than 100,000/mm3; No prior clotting disorder unless therapeutically anticoagulated - Hepatic: Bilirubin less than the upper limit of normal; SGOT or SGPT less than 1.5 times normal - Renal: BUN less than 1.5 times normal; Creatinine less than 1.5 times normal - Cardiovascular: No prior thromboembolism unless therapeutically anticoagulated - Other: No symptomatic ascites, pleural effusion or peripheral edema; No serious medical or psychiatric illness; No prior malignancy other than curatively treated carcinoma in situ of the cervix or skin cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AmyTiersten, Study Chair, Herbert Irving Comprehensive Cancer Center
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Additional Information:
Study ID Numbers: CDR0000065737; CPMC-IRB-7929,NCI-V97-1325
Study Start Date: February 1997
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003066
Other Recurrent Breast Cancer Studies:
1. Capecitabine, Paclitaxel, and Trastuzumab in Treating Patients With Metastatic Breast Cancer
2. Vinorelbine Plus Fluorouracil in Treating Women With Metastatic Breast Cancer
3. Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer
4. Marimastat or No Further Therapy in Treating Women With Metastatic Breast Cancer That Is Responding or Stable Following Chemotherapy
5. Bexarotene in Treating Patients With Metastatic Breast Cancer
Related Studies:
Other recurrent breast cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Docetaxel Combined With Estramustine in Treating Patients With Metastatic Breast Cancer
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