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Irinotecan Combined With Infusional 5-FU/Folinic Acid or Capecitabine and the Role of Celecoxib in Patients With Metastatic Colorectal Cancer

Phase 3
18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

Irinotecan Combined With Infusional 5-FU/Folinic Acid or Capecitabine and the Role of Celecoxib in Patients With Metastatic Colorectal Cancer


- Compare the progression-free survival of patients with metastatic colorectal cancer
treated with capecitabine and irinotecan vs fluorouracil, leucovorin calcium, and
irinotecan with vs without celecoxib.

- Compare the safety of these regimens in these patients.

- Compare the response rate in patients treated with these regimens.

- Compare the time to treatment failure and overall survival of patients treated with
these regimens.

OUTLINE: This is a randomized, double-blind*, multicenter study. Patients are stratified
according to participating center, prior adjuvant therapy (yes vs no), and risk group (poor
vs intermediate vs good). Patients are randomized to 1 of 4 treatment arms.

- Arm I: Patients receive irinotecan IV over 30-90 minutes on days 1 and 22; oral
capecitabine twice daily on days 1-15 and 22-36; and oral celecoxib twice daily on days

- Arm II: Patients receive irinotecan and capecitabine as in arm I and oral placebo twice
daily on days 1-42.

- Arm III: Patients receive irinotecan IV over 30-90 minutes on days 1, 15, and 29;
leucovorin calcium (CF) IV over 2 hours and fluorouracil (5-FU) IV over 22 hours on
days 1, 2, 15, 16, 29, and 30; and oral celecoxib twice daily on days 1-42.

- Arm IV: Patients receive irinotecan, CF, and 5-FU as in arm III and oral placebo twice
daily on days 1-42.

In all arms, treatment repeats every 6 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity. If all chemotherapy is discontinued due to toxicity,
patients may continue celecoxib or placebo until disease progression, unacceptable toxicity,
or starting a new cytotoxic regimen.

NOTE: *The double-blind treatment only applies to the celecoxib and placebo randomization

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 692 patients (173 per treatment arm) will be accrued for this
study within 3.5 years.

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the colon or rectum

- Metastatic disease

- Measurable disease

- Patients who received prior radiotherapy must have measurable or evaluable
disease outside the radiotherapy field

- No CNS metastases



- 18 and over

Performance status

- WHO 0-2

Life expectancy

- Not specified


- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 2 times upper limit of normal (ULN)

- AST and ALT no greater than 2.5 times ULN (5 times ULN in the presence of liver


- Creatinine clearance at least 51 mL/min

- No severe renal impairment


- No severe cardiac disease

- No uncontrolled angina pectoris

- No myocardial infarction within the past 6 months


- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 6 months after study

- No active Crohn's disease

- No other malignancy except adequately treated carcinoma in situ of the cervix or
nonmelanoma skin cancer

- No other uncontrolled severe medical condition

- No psychological, familial, sociological, or geographical condition that would
preclude study compliance and follow-up


Biologic therapy

- No concurrent active or passive immunotherapy for colon cancer


- No prior chemotherapy for metastatic disease

Endocrine therapy

- Not specified


- See Disease Characteristics

- At least 4 weeks since prior radiotherapy

- No concurrent radiotherapy


- Not specified


- At least 6 months since prior adjuvant therapy

- More than 4 weeks since prior investigational drugs

- No concurrent sorivudine or chemically related analogues (e.g., brivudine)

- No other concurrent investigational drugs

- No other concurrent cytotoxic agents

- No concurrent prophylactic fluconazole

- No concurrent or planned cyclo-oxygenase-2 (COX-2) inhibitors or nonsteroidal
anti-inflammatory drugs

- No concurrent chronic use of full-dose aspirin (325 mg/day or greater)

- Concurrent low-dose (cardioprotective) aspirin prophylaxis (no more than 325 mg
every other day OR no more than 162.5 mg per day) allowed

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Claus-Henning Koehne, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Klinikum Oldenburg


United States: Federal Government

Study ID:




Start Date:

May 2003

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • stage IV colon cancer
  • stage IV rectal cancer
  • Colorectal Neoplasms