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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00049335
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 3, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: capecitabine Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : February 2003
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Capecitabine
Capecitabine 1,000 mg/m^2/dose (2,000 mg/m^2/day) BID, PO, Days 1-14 of 21 day cycle.
Drug: capecitabine
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

Primary Outcome Measures :
  1. Feasibility of enrolling patients aged 70 years or older to a Phase II trial including pharmacokinetic sampling [ Time Frame: Registration ]

Secondary Outcome Measures :
  1. 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 ]
  2. Toxicity [ Time Frame: 3 years ]
  3. 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 ]
  4. Assess whether patients under 60 years have clinical pharmacologic parameters similar to those reported in the literature [ Time Frame: 3 years ]
  5. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 70 and over OR
  • 18 to 59

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified


  • Absolute granulocyte count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • SGOT (serum glutamate oxaloacetate transaminase) or SGPT (serum glutamate pyruvate transaminase) no greater than 2 times ULN


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


  • 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


Biologic therapy

  • Not specified


  • 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


  • Not specified


  • Not specified


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00049335

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Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
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Study Chair: Heinz-Josef Lenz, MD University of Southern California
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Responsible Party: Southwest Oncology Group Identifier: NCT00049335    
Other Study ID Numbers: CDR0000258049
S0030 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 3, 2013
Last Verified: January 2013
Keywords provided by Southwest Oncology Group:
recurrent colon cancer
stage IV colon cancer
recurrent rectal cancer
stage IV rectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents