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Multicenter Phase III Open Label Randomized Trial Comparing CPT-11 In Combination With A 5-FU/FA Infusional Regimen To The Same 5-FU/FA Infusional Regimen Alone As Adjuvant Treatment Of Stage III Colon Cancer


Phase 3
18 Years
75 Years
Not Enrolling
Both
Colorectal Cancer

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Trial Information

Multicenter Phase III Open Label Randomized Trial Comparing CPT-11 In Combination With A 5-FU/FA Infusional Regimen To The Same 5-FU/FA Infusional Regimen Alone As Adjuvant Treatment Of Stage III Colon Cancer


OBJECTIVES:

- Compare the disease-free survival at 3 years of patients with resected stage III
colorectal cancer treated with adjuvant fluorouracil and leucovorin calcium with or
without irinotecan.

- Compare the disease-free and overall survival at 5 years of patients treated with these
regimens.

- Compare the safety profiles of these treatment regimens in these patients.

- Compare the quality-adjusted survival of patients treated with these regimens.

- Correlate the expression of putative prognostic markers (thymidylate synthase,
telomerase, topoisomerase) with disease-free and overall survival of patients treated
with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to participating center. Patients are randomized to 1 of 2 treatment arms.

Arm I

- Patients receive irinotecan IV over 30-90 minutes, leucovorin calcium IV over 2 hours,
and fluorouracil IV over 24 hours weekly for 6 weeks. Courses repeat every 7 weeks for
up to 4 courses in the absence of disease progression or unacceptable toxicity.

- As an alternative schedule, patients may receive irinotecan IV over 30-90 minutes and
day 1 and leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days
1 and 2 every 2 weeks for 6 weeks. Treatment repeats every 6 weeks for up to 4 courses
in the absence of disease progression or unacceptable toxicity.

Arm II

- Patients receive leucovorin calcium and fluorouracil as in arm I. Quality of life may
be assessed at baseline; prior to courses 2, 3, and 4; and at 1, 3, and 6 months.

Patients are followed every 3 months for 3 years and then every 6 months for 2 years.

PROJECTED ACCRUAL: Approximately 1800 patients (900 per arm) will be accrued for this study
within 24 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the colon or intraperitoneal rectum

- Stage III

- Completely resected within the past 3-8 weeks

- No gross or microscopic evidence of residual disease after surgery

- No rectal cancer requiring total meso-rectal resection or pre- or postoperative
radiotherapy

- No prior curatively resected synchronous metastasis of colorectal cancer

PATIENT CHARACTERISTICS:

Age:

- 18 to 75

Performance status:

- WHO 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 2,000/mm^3

- Platelet count at least 150,000/mm^3

- Hemoglobin at least 10 g/dL

Hepatic:

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

- AST and ALT no greater than 2.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No myocardial infarction with the past year

- No uncontrolled hypertension

- No high-risk uncontrolled arrhythmia

- No unstable angina pectoris

Other:

- HIV negative

- No chronic diarrhea

- No current chronic inflammation or subobstruction of bowel after surgery

- No active uncontrolled infection

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

- No psychological, social, familial, or geographical condition that would preclude
follow-up

- Not pregnant or nursing

- Negative pregnancy test

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior antineoplastic chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

Surgery:

- See Disease Characteristics

- No prior celioscopic resection of primary tumor

Other:

- At least 30 days since prior participation in another clinical trial with any
investigational drug

- No other concurrent experimental drugs

- No other concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Eric Van Cutsem, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

U.Z. Gasthuisberg

Authority:

United States: Federal Government

Study ID:

XRP 4174B-307

NCT ID:

NCT00026273

Start Date:

January 2001

Completion Date:

Related Keywords:

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

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