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Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsor: European Institute of Oncology
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003063
  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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: Adjuvant Chemoimmunotherapy for Colorectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Fluorouracil Leucovorin Levamisole Levamisole hydrochloride Citrovorum factor Interferon alfa-2a Interferon alfa-n1 Leucovorin Calcium Folinic acid calcium salt pentahydrate Interferons
U.S. FDA Resources

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
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:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: CDR0000065728, CNR-TONE-01, EU-97011
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003063     History of Changes
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:
Antimetabolites
Anti-Infective Agents
Interferon Type I, Recombinant
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Gastrointestinal Diseases
Colonic Diseases
Physiological Effects of Drugs
Leucovorin
Rectal Diseases
Antiparasitic Agents
Neoplasms by Site
Vitamins
 Therapeutic Uses
Micronutrients
Growth Inhibitors
Angiogenesis Modulating Agents
Levamisole
Antinematodal Agents
Interferon-alpha
Vitamin B Complex
Digestive System Neoplasms
Growth Substances
Interferons
Adjuvants, Immunologic
Anthelmintics
Intestinal Diseases
Immunosuppressive Agents

ClinicalTrials.gov processed this record on November 27, 2009



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