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

  Hide Study Locations
George Papanicolaou General Hospital
Thessaloniki, Greece, 57010
Ospedale Bassini
Balsamo Cinisello, Italy, 20092
Universita Degli Studi di Bari Policlinico
Bari, Italy, 70124
Spedali Civili
Brescia, Italy, 25124
Cattedra di Oncologia Medica - Universita
Cagliari, Italy, 09124
Ospedale Oncologico A. Businco
Cagliari, Italy, 09124
Ospedale San Michele
Cagliari, Italy, 9100
Ospedale Sant Anna
Como, Italy, 22100
Ospedale Valduce
Como, Italy, 22100
Ospedale Di Conselice
Conselice, Italy, 48017
Ospedale Civile Cosenza
Cosenza, Italy, 87100
Ospedale Maggiore Crema
Crema, Italy, 26013
Ospedale Santa Croce
Cuneo, Italy, 12100
Ospedale Civile Feltre
Feltre, Italy, 32100
Universita di Ferrara
Ferrara, Italy, 44100
Universita Degli Studi di Firenze - Policlin. di Careggi
Firenze (Florence), Italy, 1 (50134)
Policlinico di Careggi
Firenze (Florence), Italy, 50134
U.S.L. 10 Villa Ognissanti
Firenze, Italy, 50139
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), Italy, 16132
Ospedale San Martino/Cliniche Universitarie Convenzionate
Genoa (Genova), Italy, 16132
Ospedale Galliera Oncologia
Genova (Genoa), Italy, 16128
Ospedale Di Gorgonzola
Gorgonzola, Italy, 20064
Ospedale Legnago USSL 21
Legnago, Italy, 37045
Ospedale Maggiore Lodi
Lodi, Italy, I-20075
Ospedale Umberto I
Lugo DI Romagna, Italy, 48022
U.S.S.L. 72 Magenta
Magenta, Italy, 20013
Carlo Poma Hospital
Mantova, Italy, 46100
Ospedale Di Predabissi Melegnano
Melegnano, Italy, 20077
Azienda USSL NO 8
Merate, Italy, 22055
Instituto Di Oncologia
Messina, Italy, 98122
Ospedale Civile Umberto I
Mestre, Italy, 30174
Ospedale San Carlo Borromeo
Milano (Milan), Italy, 20153
Ospedale Luigi Sacco
Milano (Milan), Italy, 20157
Ospedale Maggiore Ca Granda
Milano (Milan), Italy, 20162
Ospedale San Giuseppe
Milano, Italy, 20100
Consorzio Provinciale Antitubercolare
Milano, Italy, 20124
Istituto Scientifico H.S. Raffaele
Milano, Italy, 20132
Istituto Di Science Biomediche San Paolo
Milano, Italy, 20142
Casa Di Cura San Ambrogio
Milano, Italy, 20149
Ospedale Santa Croce
Moncalieri, Italy, 10024
Nuovo Ospedale San Gerardo
Monza, Italy, 20052
Ospedale Civile Asilo Vittoria
Mortara, Italy, 27036
Federico II University Medical School
Naples (Napoli), Italy, 80131
Istituto Tumori/Fondazione Pascale
Naples (Napoli), Italy, 80131
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, Italy, 80131
Ospedale Vincenzo Monaldi
Napoli, Italy, 80131
Ospedale C. Ascalesi
Napoli, Italy, 80139
Ospedale Civile Negrar
Negrar, Italy, 37024
Azienda Ospedaliera di Padova
Padova (Padua), Italy, 35128
University of Padua
Padua, Italy, 35128
Ospedale Civico E Benefratelli
Palermo, Italy, 90127
Ospedale Maggiore Parma
Parma, Italy, 43100
Ospedale Torrette University Ancona
Parma, Italy, 43100
Ospedale Silvestrini
Perugia, Italy, 06132
Ospedale Agnelli
Pinerolo, Italy, 10064
Ospedale Sta. Maria Delle Croci
Ravenna, Italy, 48100
Azienda Ospedaliera
Reggio Emilia, Italy, 42100
Ospedale Civile Rho
Rho, Italy, 20017
Istituti Fisioterapici Ospitalieri - Roma
Rome, Italy, 00128
Ospedale San Filippo Neri
Rome, Italy, 00135
Ospedale Carlo Forlanini
Rome, Italy, 00149
Ospedale S. Camillo-Forlanini
Rome, Italy, 00151
Azienda Policlinico Umberto Primo
Rome, Italy, 00161
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, Italy, 00168
Policlinico Militare Celio
Rome, Italy, 00184
ASL NO. 1 Imperiese
San Remo, Italy, 18038
Azienda USSL No 4
Saronno, Italy, 21047
Istituto Clinica Medica
Sassari, Italy, 07100
Ospedale S.S. Annunziata
Savigliano, Italy, 12038
Ospedale Sesto San Giovanni
Sesto San Giovanni, Italy, 20099
Azienda Ospedaliera S. Maria
Terni, Italy, 05100
Ospedale Generale Prov. Boldrini
Thiene, Italy, 36016
Dispensario Igiene Sociale
Toino, Italy, 10100
Clinica Universita
Torino, Italy, 10126
Universita Torino
Torino, Italy, 10126
Ospedale S. Chiara
Trento, Italy, 38100
Ospedale San Isidoro
Trescore Balneario, Italy, 24069
Ospedale General Regional Ca Foncello
Treviso, Italy, 31100
Ospedale Maggiore dell' Universita
Trieste, Italy, 34100
Ospedale Cattinara
Trieste, Italy
Cattedra di Immunologia Clinica
Turin (TO), Italy, 10128
Universita Degli Studi di Udine
Udine, Italy, 33100
Ospedale di Circolo e Fondazione Macchi
Varese, Italy, 21100
Ospedale San Bortolo
Vicenza, Italy, 36100
Korea, Republic of
Inha University Hospital
Incheon, Korea, Republic of
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