Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer - Full Text View

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

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Locations

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

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