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Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer

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: NCT00030797
Recruitment Status : Completed
First Posted : June 25, 2003
Last Update Posted : May 15, 2012
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced or metastatic colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Irinotecan 70 mg/m2 Drug: Irinotecan 240 mg/m2 Phase 2

Detailed Description:


  • Compare the efficacy of different schedules of irinotecan in combination with capecitabine as first-line therapy, in terms of objective response rate, in patients with advanced or metastatic colorectal cancer.
  • Compare the time to treatment failure, time to progression, and overall survival of patients treated with these regimens.
  • Compare the safety profile, in terms of toxicity, of these regimens in these patients.
  • Determine the quality of life in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs 1); disease symptoms, including pain, weight loss, loss of appetite, malaise, and fever of unknown origin (yes vs no); weight loss during the past 6 months (more than 5% vs 5% or less); and disease-free interval (more than 6 months vs 6 months or less). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive irinotecan IV over 1 hour on days 1, 8, 15, 22, and 29 and oral capecitabine twice daily on days 1-14 and 22-35.
  • Arm II: Patients receive irinotecan IV over 1 hour on days 1 and 22 and oral capecitabine as in arm I.

Treatment in both arms repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, on day 1 of each course, and at the first visit after treatment failure.

Patients are followed every 12 weeks for 1 year and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 28-74 patients (14-37 per treatment arm) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial Of Capecitabine And Different Schedules Of Irinotecan As First Line Treatment For Advanced Or Metastatic Colorectal Cancer
Study Start Date : February 2001
Actual Primary Completion Date : May 2002
Actual Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Arm A
Irinotecan i.v. 70 mg/m2, day 1, 8, 15, 22, 29; Capecitabine p.o. 2 x 1000 mg/m2, d1-14, d22-35;
Drug: Irinotecan 70 mg/m2
Irinotecan i.v. 70 mg/m2, day 1, 8, 15, 22, 29

Active Comparator: Arm B
Irinotecan i.v. 240 mg/m2 day 1 and day 22; Capecitabine p.o. 2 x 1000 mg/m2, d1-14, d22-35;
Drug: Irinotecan 240 mg/m2
Irinotecan i.v. 240 mg/m2 day 1 and day 22

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed advanced or metastatic colorectal cancer

    • Unresectable disease
  • At least 1 bidimensionally measurable lesion

    • At least 2 cm in perpendicular diameters
  • No evidence of CNS metastases



  • 18 to 75

Performance status:

  • 0-1

Life expectancy:

  • At least 3 months


  • WBC at least 3,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin normal
  • SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN


  • Creatinine no greater than 1.25 times ULN


  • No clinically significant cardiac disease
  • No congestive heart failure
  • No New York Heart Association class III or IV heart disease
  • No symptomatic coronary artery disease
  • No uncontrolled cardiac arrhythmia
  • No myocardial infarction within the past year


  • No evidence of dysphagia
  • No malabsorption or intestinal obstruction that would affect absorption or excretion of study drugs
  • No chronic diarrhea


  • No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer
  • No psychiatric disability that would preclude study compliance
  • No other significant medical condition
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • No prior chemotherapy for advanced or metastatic disease

Endocrine therapy:

  • Not specified


  • Not specified


  • At least 4 weeks since prior major surgery to the gastrointestinal tract


  • No concurrent therapy for history of seizures or CNS disorder

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): NCT00030797

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Inselspital, Bern
Bern, Switzerland, CH-3010
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
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Study Chair: Markus M. Borner, MD University Hospital Inselspital, Berne

Publications of Results:
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Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT00030797    
Other Study ID Numbers: SAKK 41/00
First Posted: June 25, 2003    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012
Keywords provided by Swiss Group for Clinical Cancer Research:
stage III colon cancer
stage IV colon cancer
stage III 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
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors