Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer

Phase 1

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00083148
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Irinotecan may help capecitabine kill more tumor cells by making tumor cells more sensitive to the drug.

PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan and capecitabine in treating women with advanced breast cancer.

Detailed Description

OBJECTIVES:

* Determine the maximum tolerated dose of capecitabine and irinotecan in women with advanced breast cancer.

* Determine the degree of accumulation of cells in S-phase in tumor biopsies from patients treated with this regimen.

* Determine the dose-limiting toxicity and other major or unusual toxic effects of this regimen in these patients.

* Determine any antitumor activity of this regimen in these patients.

* Determine the pharmacokinetics of this regimen, including the active metabolite SN-38, in these patients.

* Correlate pharmacokinetic parameters of this regimen with the biological changes observed in these patients.

* Determine, preliminarily, the relationship of tumor response with modulation of S-phase in patients treated with this regimen.

OUTLINE: This is a dose-escalation study.

Patients receive irinotecan IV over 1.5 hours on days 1, 8, 22, and 29 and oral capecitabine twice daily on days 1-14 and 23-36. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 8-37 patients will be accrued for this study within 18-24 months.

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2004-05-14
• Study First Submitted QC: 2004-05-14
• Study First Posted: 2004-05-17
• Primary Completion: 2005-03
• Study Completion: 2006-09
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-07
• Last Update Posted: 2011-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States