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Paclitaxel and Capecitabine in Treating Women With Metastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005649
First received: May 2, 2000
Last updated: July 23, 2008
Last verified: December 2006
History of Changes

May 2, 2000
July 23, 2008
July 1998
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Complete list of historical versions of study NCT00005649 on ClinicalTrials.gov Archive Site
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Paclitaxel and Capecitabine in Treating Women With Metastatic Breast Cancer
An Open-Label Combination Study of Capecitabine and Standard Paclitaxel Therapy as First or Second Line Therapy in Women With Metastatic Breast Carcinoma

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 paclitaxel and capecitabine in treating women who have metastatic breast cancer.

OBJECTIVES: I. Determine the safety, response rate, and efficacy of combination therapy with paclitaxel and capecitabine as first or second line therapy in women with metastatic breast cancer.

OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours on day 1 and capecitabine orally twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed for survival status every 3 months upon completion of treatment.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Interventional
Phase 2
Primary Purpose: Treatment
Breast Cancer
  • Drug: capecitabine
  • Drug: paclitaxel
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Gradishar WJ, Meza LA, Amin B, Samid D, Hill T, Chen YM, Lower EE, Marcom PK. Capecitabine plus paclitaxel as front-line combination therapy for metastatic breast cancer: a multicenter phase II study. J Clin Oncol. 2004 Jun 15;22(12):2321-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic breast cancer Bidimensionally measurable disease Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 to 75 Sex: Female Menopausal status: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: ANC at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) Renal: Creatinine less than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Eligible patients may have received prior chemotherapy in metastatic or adjuvant setting with the following exceptions: At least 12 months since prior fluoropyrimidine therapy At least 12 months since prior taxane therapy Only 1 previous chemotherapeutic regimen in the metastatic setting Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified
Female
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005649
CDR0000067869, ROCHE-M66104C
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Hoffmann-La Roche
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Study Chair: William J. Gradishar, MD Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP