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Docetaxel Combined With Estramustine in Treating Women With Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003066
Recruitment Status : Unknown
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : February 16, 2004
Last Update Posted : January 6, 2014
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: docetaxel Drug: estramustine phosphate sodium Phase 2

Detailed Description:

OBJECTIVES: I. Determine the response rate, duration of response, duration of survival, and quality of life effects of docetaxel and estramustine combination in women with metastatic breast cancer.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Primary Purpose: Treatment
Official Title: Phase II Evaluation of Docetaxel Combined With Estramustine Phosphate in Patients With Metastatic Breast Cancer
Study Start Date : February 1997

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003066

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United States, New York
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center
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Study Chair: Amy D. Tiersten, MD Herbert Irving Comprehensive Cancer Center

Layout table for additonal information Identifier: NCT00003066    
Other Study ID Numbers: CDR0000065737
First Posted: February 16, 2004    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: December 2006
Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents, Hormonal