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

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: capecitabine

• Registration Number: NCT00049335
• Lead Sponsor: SWOG Cancer Research Network

Brief 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.

Study Timeline

• Study First Submitted: 2002-11-12
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Study Start: 2003-02
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-02
• Last Update Posted: 2013-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capecitabine	capecitabine	Capecitabine 1,000 mg/m\^2/dose (2,000 mg/m\^2/day) BID, PO, Days 1-14 of 21 day cycle.

Primary Outcome Measures

Name	Time	Method
Feasibility of enrolling patients aged 70 years or older to a Phase II trial including pharmacokinetic sampling	Registration

Secondary Outcome Measures

Name	Time	Method
Efficacy of capecitabine for management of advanced colorectal cancer patients aged 70 years or older based on objective response rate and 2 year survival	2 years
Toxicity	3 years
Assess parameters of clinical pharmacology of capecitabine in patients aged 70 years or older including half life value(s), AUC (area under curve) and steady state levels	3 years
Assess whether patients under 60 years have clinical pharmacologic parameters similar to those reported in the literature	3 years
Explore, at a preliminary level, the feasibility of studying genetic polymorphisms and gene expression levels of enzymes involved in drug metabolism and resistance to capecitabine	3 years

Trial Locations

Locations (90)

MBCCOP - Gulf Coast; 🇺🇸 Mobile, Alabama, United States

CCOP - Western Regional, Arizona; 🇺🇸 Phoenix, Arizona, United States

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden); 🇺🇸 Phoenix, Arizona, United States

Veterans Affairs Medical Center - Tucson; 🇺🇸 Tucson, Arizona, United States

Arizona Cancer Center at University of Arizona Health Sciences Center; 🇺🇸 Tucson, Arizona, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Veterans Affairs Medical Center - Little Rock; 🇺🇸 Little Rock, Arkansas, United States

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States

Veterans Affairs Medical Center - Loma Linda (Pettis); 🇺🇸 Loma Linda, California, United States

USC/Norris Comprehensive Cancer Center and Hospital; 🇺🇸 Los Angeles, California, United States

Scroll for more (80 remaining)