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A Randomized Phase II Trial Of Capecitabine And Different Schedules Of Irinotecan As First Line Treatment For Advanced Or Metastatic Colorectal Cancer

Phase 2
18 Years
75 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

A Randomized Phase II Trial Of Capecitabine And Different Schedules Of Irinotecan As First Line Treatment For Advanced Or Metastatic Colorectal Cancer


- 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.

Inclusion Criteria


- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Markus M. Borner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital Inselspital, Berne


Switzerland: Swissmedic

Study ID:

SAKK 41/00



Start Date:

February 2001

Completion Date:

December 2003

Related Keywords:

  • Colorectal Cancer
  • stage III colon cancer
  • stage IV colon cancer
  • stage III rectal cancer
  • stage IV rectal cancer
  • Colorectal Neoplasms