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Docetaxel Combined With Estramustine in Treating Patients With Metastatic Breast Cancer - Article


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Docetaxel

Taxotere



Clinical Trial: Docetaxel Combined With Estramustine in Treating Patients With Metastatic Breast Cancer

This study is no longer recruiting patients.

Sponsored by: Herbert Irving Comprehensive Cancer Center
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
stage IV breast cancer
recurrent breast cancer
 Drug: docetaxel
 Drug: estramustine
Phase II

MedlinePlus related topics:  Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Docetaxel Combined with Estramustine in Patients with Metastatic Breast Cancer

Further Study Details: 

Study start: February 1997

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

Ages Eligible for Study:  18 Years and above

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

Location Information


New York
      Herbert Irving Comprehensive Cancer Center, New York,  New York,  10032,  United States

Study chairs or principal investigators

Amy D. Tiersten,  Study Chair,  Herbert Irving Comprehensive Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000065737; CPMC-IRB-7929; NCI-V97-1325
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003066
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 18, 2008



Page Updated: October 3, 2005
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