NCT00049335

S0030: Capecitabine in Treating Older Patients W/Metastatic or Recurrent Colorectal Cancer That Cannot Be Surgically Removed

Protocol For Assessment Of Capecitabine For Advanced Colorectal Cancer In Patients Aged 70 Years And Older (And In A Cohort Of Patients Younger Than 60 Years)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating older patients who have metastatic or recurrent colorectal cancer that cannot be surgically removed.

Detailed description

OBJECTIVES: * Determine the feasibility of enrolling patients aged 70 and over with unresectable metastatic or recurrent colorectal cancer to a structured phase II study. * Determine the anticancer efficacy of capecitabine, in terms of objective response rate (confirmed and unconfirmed, complete and partial responses) and 2-year survival, in these patients. * Determine the toxicity and tolerability of this drug in these patients. * Determine the feasibility of using standardized self-report measures of comorbidity, depression, and functional status of patients treated with this drug. * Determine the clinical pharmacology of this drug in these patients. * Determine whether patients under 60 years of age treated with this drug have clinical pharmacologic parameters similar to those reported in the literature. OUTLINE: This is a multicenter study. Patients are stratified according to age (70 and over vs 18 to 59). Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 3 years. PROJECTED ACCRUAL: A total of 80 patients (60 patients aged 70 and over, 20 patients aged 18 to 59) will be accrued for this study.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	capecitabine	1,000 mg/m\^2/dose (2,000 mg/m\^2/day) BID, PO, on Days 1-14 of 21 day cycle

Timeline

• Start date: 2003-02-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2003-01-27
• Last updated: 2013-01-03

Locations

90 sites across 1 country: United States