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Capecitabine and Tipifarnib in Treating Women With Taxane-Resistant Metastatic Breast Cancer

2014-08-27 03:54:37 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving capecitabine together with tipifarnib may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving capecitabine together with tipifarnib works in treating women with taxane-resistant metastatic breast cancer.

Description

OBJECTIVES:

Primary

- Determine the response rate in women with taxane-resistant metastatic breast cancer treated with capecitabine and tipifarnib.

Secondary

- Determine the toxicity of this regimen in these patients.

- Determine the progression-free survival, time to treatment failure, and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 4 additional courses beyond documentation of CR.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 7 months.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

capecitabine, tipifarnib

Location

Memorial Medical Center Cancer Services
Modesto
California
United States
95355

Status

Completed

Source

Eastern Cooperative Oncology Group

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:37-0400

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Medical and Biotech [MESH] Definitions

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).

Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.

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Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.

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