Paclitaxel and Capecitabine in Treating Women With Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

An Open-Label Combination Study of Capecitabine and Standard Paclitaxel Therapy as First or Second Line Therapy in Women With Metastatic Breast Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005649
• Other study ID #: CDR0000067869
• Secondary ID: ROCHE-M66104C
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2000
• Last updated: August 15, 2017
• Start date: July 1998
• Est. completion date: July 4, 2002

Study information

• Verified date: August 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 4, 2002
• Est. primary completion date: July 4, 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• capecitabine

• paclitaxel

Locations

Country	Name	City	State
United States	PPD Development	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation