S0030: Capecitabine in Treating Older Patients W/Metastatic or Recurrent Colorectal Cancer That Cannot Be Surgically Removed
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- Feasibility of enrolling patients aged 70 years or older to a Phase II trial including pharmacokinetic sampling [ Time Frame: Registration ] [ Designated as safety issue: No ]
- Efficacy of capecitabine for management of advanced colorectal cancer patients aged 70 years or older based on objective response rate and 2 year survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- 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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Assess whether patients under 60 years have clinical pharmacologic parameters similar to those reported in the literature [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2003|
|Study Completion Date:||June 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Capecitabine 1,000 mg/m^2/dose (2,000 mg/m^2/day) BID, PO, Days 1-14 of 21 day cycle.
1,000 mg/m^2/dose (2,000 mg/m^2/day) BID, PO, on Days 1-14 of 21 day cycle
Other Name: NSC-712807
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049335
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|Study Chair:||Heinz-Josef Lenz, MD||University of Southern California|