Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Capecitabine in Treating Older Patients With Metastatic or Recurrent Colorectal Cancer That Cannot Be Surgically Removed

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	70 and over OR 18 to 59	NCI	SWOG-S0030 S0030, NCT00049335

Objectives

1. Determine the feasibility of enrolling patients aged 70 and over with unresectable metastatic or recurrent colorectal cancer to a structured phase II study.
2. 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.
3. Determine the toxicity and tolerability of this drug in these patients.
4. Determine the feasibility of using standardized self-report measures of comorbidity, depression, and functional status of patients treated with this drug.
5. Determine the clinical pharmacology of this drug in these patients.
6. Determine whether patients under 60 years of age treated with this drug have clinical pharmacologic parameters similar to those reported in the literature.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed metastatic or recurrent colorectal cancer not amenable to surgical resection



• Measurable disease



• No known brain metastases by MRI or CT scan

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for advanced cancer
• Prior adjuvant chemotherapy allowed provided recurrence occurred more than 1 year after the last treatment

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• At least 4 weeks since prior sorivudine or brivudine
• No concurrent sorivudine or brivudine

Patient Characteristics:

Age

• 70 and over

  OR

• 18 to 59

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count at least 1,000/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 2 times upper limit of normal (ULN)
• SGOT or SGPT no greater than 2 times ULN

Renal

• Creatinine no greater than 2 times ULN
• Creatinine clearance greater than 50 mL/min

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• HIV negative
• No known seizure disorder
• No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer currently in complete remission, or any other cancer for which the patient has been disease free for 5 years

Expected Enrollment

A total of 80 patients (60 patients aged 70 and over, 20 patients aged 18 to 59) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Heinz-Josef Lenz, MD, Protocol chair		Ph: 323-865-3955; 800-865-0102 Email: lenz_h@ccnt.usc.edu

Registry Information
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)
Trial Start Date		2003-02-01
Trial Completion Date		2007-06-01
Registered in ClinicalTrials.gov		NCT00049335
Date Submitted to PDQ		2002-09-11
Information Last Verified		2004-11-23
NCI Grant/Contract Number		CA32102

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