Biological Therapy With Combination Chemotherapy in Patients With 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: NCT00003063
Recruitment Status : Unknown
Verified November 2005 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of treatment using levamisole with treatment using interferon alfa and combination chemotherapy consisting of fluorouracil and leucovorin in patients with stage II or stage III colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: recombinant interferon alfa Drug: fluorouracil Drug: leucovorin calcium Drug: levamisole hydrochloride Phase 3

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1050 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Adjuvant Chemoimmunotherapy for Colorectal Cancer
Study Start Date : November 1991

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 75 and under

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified


  • WBC at least 3500/mm3
  • Platelet count at least 100,000/mm3


  • Bilirubin no greater than 2.0 mg/dL
  • SGPT less than 2 times upper limit of normal


  • Creatinine no greater than 2.0 mg/dL


  • No serious cardiac ischemia


  • Adequate metabolic functions
  • No prior neoplasm
  • No prior/concurrent illness
  • No insulin-dependent diabetes


Biologic therapy

  • No prior immunotherapy for the current cancer


  • No prior chemotherapy for the current cancer

Endocrine therapy

  • Not specified


  • No prior radiotherapy for the current cancer


  • Not specified

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): NCT00003063

  Show 85 Study Locations
Sponsors and Collaborators
European Institute of Oncology
Study Chair: Francesco Tonelli, MD Universita Degli Studi di Florence - Policlinico di Careggi Identifier: NCT00003063     History of Changes
Other Study ID Numbers: CDR0000065728
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: November 2005

Keywords provided by National Cancer Institute (NCI):
stage II colon cancer
stage III colon cancer
stage II rectal cancer
stage III rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents
Adjuvants, Immunologic
Antinematodal Agents