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Docetaxel Combined With Estramustine in Treating Women With Metastatic Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes
Sponsored by: Herbert Irving Comprehensive Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003066
  Purpose

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 Intervention Phase
Breast Cancer
Drug: docetaxel
Drug: estramustine phosphate sodium
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Evaluation of Docetaxel Combined With Estramustine Phosphate in Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 40
Study Start Date: February 1997
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003066

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

Additional Information:
No publications provided

Study ID Numbers: CDR0000065737, CPMC-IRB-7929, NCI-V97-1325
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003066     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer

Study placed in the following topic categories:
Docetaxel
Antineoplastic Agents, Hormonal
Skin Diseases
Estramustine
Breast Neoplasms
Antineoplastic Agents, Alkylating
Alkylating Agents
Breast Diseases
Recurrence

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estramustine
Breast Neoplasms
Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Breast Diseases

ClinicalTrials.gov processed this record on July 02, 2009