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Adjuvant Chemoimmunotherapy for Colorectal Cancer


Phase 3
N/A
75 Years
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

Adjuvant Chemoimmunotherapy for Colorectal Cancer


OBJECTIVES:

- Assess the efficacy of the addition of levamisole or alfa interferon to fluorouracil
and leucovorin calcium (folinic acid) as an adjuvant treatment of intraperitoneal
colorectal cancer.

OUTLINE: This is a three arm study. Patients are randomized to receive either levamisole,
alfa interferon, or no treatment.

- Arm I: Patients receive levamisole PO for 3 days every 2 weeks for 6 months before and
after surgery. Fluorouracil IV bolus and leucovorin calcium (folinic acid) IV over 1
hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery.

- Arm II: Patients receive alfa interferon-2a SC on 3 alternate days for a week before
surgery and for 6 months after surgery. Fluorouracil IV bolus and folinic acid IV over
1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery.

- Arm III: Patients undergo surgery followed by fluorouracil IV bolus and folinic acid IV
over 1 hour on days 1-5 every 4 weeks for 6 cycles.

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

PROJECTED ACCRUAL: 350 patients per arm will be accrued for a total of 1,050 patients.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage T3-T4 N0 or T1-T4 N1-3 colorectal cancer

- No evidence of residual disease after surgery

- Tumor located above peritoneal reflection

- No distant metastases

PATIENT CHARACTERISTICS:

Age:

- 75 and under

Performance status:

- WHO 0-1

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3500/mm3

- Platelet count at least 100,000/mm3

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- SGPT less than 2 times upper limit of normal

Renal:

- Creatinine no greater than 2.0 mg/dL

Cardiovascular:

- No serious cardiac ischemia

Other:

- Adequate metabolic functions

- No prior neoplasm

- No prior/concurrent illness

- No insulin-dependent diabetes

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior immunotherapy for the current cancer

Chemotherapy

- No prior chemotherapy for the current cancer

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy for the current cancer

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Francesco Tonelli, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Universita Degli Studi di Florence - Policlinico di Careggi

Authority:

United States: Federal Government

Study ID:

CDR0000065728

NCT ID:

NCT00003063

Start Date:

November 1991

Completion Date:

Related Keywords:

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

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