Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003063
First received: November 1, 1999
Last updated: September 19, 2013
Last verified: November 2005
  Purpose

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 Intervention Phase
Colorectal Cancer
Biological: recombinant interferon alfa
Drug: fluorouracil
Drug: leucovorin calcium
Drug: levamisole hydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Adjuvant Chemoimmunotherapy for Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 1050
Study Start Date: November 1991
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003063

  Show 85 Study Locations
Sponsors and Collaborators
European Institute of Oncology
Investigators
Study Chair: Francesco Tonelli, MD Universita Degli Studi di Florence - Policlinico di Careggi
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003063     History of Changes
Other Study ID Numbers: CDR0000065728, CNR-TONE-01, EU-97011
Study First Received: November 1, 1999
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

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
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Fluorouracil
Interferon-alpha
Interferons
Levamisole
Levoleucovorin
Adjuvants, Immunologic
Anthelmintics
Anti-Infective Agents
Antidotes
Antimetabolites
Antimetabolites, Antineoplastic
Antinematodal Agents
Antineoplastic Agents
Antiparasitic Agents
Antirheumatic Agents
Antiviral Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 30, 2014