Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer

NCT00003063 | Unknown Phase 3

• 3 other identifiers: CDR0000065728CNR-TONE-01EU-97011
• Study Type: interventional
• Target: 1,050
• Locations: 3 countries
• Sites: 85

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.

Conditions

Colorectal Cancer

Keywords

stage II colon cancer; stage III colon cancer; stage II rectal cancer; stage III rectal cancer

Interventions

recombinant interferon alfa BIOLOGICAL

fluorouracil DRUG

leucovorin calcium DRUG

levamisole hydrochloride DRUG

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (85)

George Papanicolaou General Hospital

Thessaloniki, 57010, Greece

Location

Ospedale Bassini

Balsamo Cinisello, 20092, Italy

Location

Universita Degli Studi di Bari Policlinico

Bari, 70124, Italy

Location

Spedali Civili

Brescia, 25124, Italy

Location

Cattedra di Oncologia Medica - Universita

Cagliari, 09124, Italy

Location

Ospedale Oncologico A. Businco

Cagliari, 09124, Italy

Location

Ospedale San Michele

Cagliari, 9100, Italy

Location

Ospedale Sant Anna

Como, 22100, Italy

Location

Ospedale Valduce

Como, 22100, Italy

Location

Ospedale Di Conselice

Conselice, 48017, Italy

Location

Ospedale Civile Cosenza

Cosenza, 87100, Italy

Location

Ospedale Maggiore Crema

Crema, 26013, Italy

Location

Ospedale Santa Croce

Cuneo, 12100, Italy

Location

Ospedale Civile Feltre

Feltre, 32100, Italy

Location

Universita di Ferrara

Ferrara, 44100, Italy

Location

Universita Degli Studi di Firenze - Policlin. di Careggi

Firenze (Florence), 1 (50134), Italy

Location

Policlinico di Careggi

Firenze (Florence), 50134, Italy

Location

U.S.L. 10 Villa Ognissanti

Florence, 50139, Italy

Location

Istituto Nazionale per la Ricerca sul Cancro

Genoa (Genova), 16132, Italy

Location

Ospedale San Martino/Cliniche Universitarie Convenzionate

Genoa (Genova), 16132, Italy

Location

Ospedale Galliera Oncologia

Genova (Genoa), 16128, Italy

Location

Ospedale Di Gorgonzola

Gorgonzola, 20064, Italy

Location

Ospedale Legnago USSL 21

Legnago, 37045, Italy

Location

Ospedale Maggiore Lodi

Lodi, I-20075, Italy

Location

Ospedale Umberto I

Lugo DI Romagna, 48022, Italy

Location

U.S.S.L. 72 Magenta

Magenta, 20013, Italy

Location

Carlo Poma Hospital

Mantova, 46100, Italy

Location

Ospedale Di Predabissi Melegnano

Melegnano, 20077, Italy

Location

Azienda USSL NO 8

Merate, 22055, Italy

Location

Instituto Di Oncologia

Messina, 98122, Italy

Location

Ospedale Civile Umberto I

Mestre, 30174, Italy

Location

Ospedale San Giuseppe

Milan, 20100, Italy

Location

Consorzio Provinciale Antitubercolare

Milan, 20124, Italy

Location

Istituto Scientifico H.S. Raffaele

Milan, 20132, Italy

Location

Istituto Di Science Biomediche San Paolo

Milan, 20142, Italy

Location

Casa Di Cura San Ambrogio

Milan, 20149, Italy

Location

Ospedale San Carlo Borromeo

Milano (Milan), 20153, Italy

Location

Ospedale Luigi Sacco

Milano (Milan), 20157, Italy

Location

Ospedale Maggiore Ca Granda

Milano (Milan), 20162, Italy

Location

Ospedale Santa Croce

Moncalieri, 10024, Italy

Location

Nuovo Ospedale San Gerardo

Monza, 20052, Italy

Location

Ospedale Civile Asilo Vittoria

Mortara, 27036, Italy

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Naples, 80131, Italy

Location

Federico II University Medical School

Naples (Napoli), 80131, Italy

Location

Istituto Tumori/Fondazione Pascale

Naples (Napoli), 80131, Italy

Location

Ospedale Vincenzo Monaldi

Napoli, 80131, Italy

Location

Ospedale C. Ascalesi

Napoli, 80139, Italy

Location

Ospedale Civile Negrar

Negrar, 37024, Italy

Location

Azienda Ospedaliera di Padova

Padova (Padua), 35128, Italy

Location

University of Padua

Padua, 35128, Italy

Location

Ospedale Civico E Benefratelli

Palermo, 90127, Italy

Location

Ospedale Maggiore Parma

Parma, 43100, Italy

Location

Ospedale Torrette University Ancona

Parma, 43100, Italy

Location

Ospedale Silvestrini

Perugia, 06132, Italy

Location

Ospedale Agnelli

Pinerolo, 10064, Italy

Location

Ospedale Sta. Maria Delle Croci

Ravenna, 48100, Italy

Location

Azienda Ospedaliera

Reggio Emilia, 42100, Italy

Location

Ospedale Civile Rho

Rho, 20017, Italy

Location

Istituti Fisioterapici Ospitalieri - Roma

Rome, 00128, Italy

Location

Ospedale San Filippo Neri

Rome, 00135, Italy

Location

Ospedale Carlo Forlanini

Rome, 00149, Italy

Location

Ospedale S. Camillo-Forlanini

Rome, 00151, Italy

Location

Azienda Policlinico Umberto Primo

Rome, 00161, Italy

Location

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

Rome, 00168, Italy

Location

Policlinico Militare Celio

Rome, 00184, Italy

Location

ASL NO. 1 Imperiese

Sanremo, 18038, Italy

Location

Azienda USSL No 4

Saronno, 21047, Italy

Location

Istituto Clinica Medica

Sassari, 07100, Italy

Location

Ospedale S.S. Annunziata

Savigliano, 12038, Italy

Location

Ospedale Sesto San Giovanni

Sesto San Giovanni, 20099, Italy

Location

Azienda Ospedaliera S. Maria

Terni, 05100, Italy

Location

Ospedale Generale Prov. Boldrini

Thiene, 36016, Italy

Location

Dispensario Igiene Sociale

Toino, 10100, Italy

Location

Clinica Universita

Torino, 10126, Italy

Location

Universita Torino

Torino, 10126, Italy

Location

Ospedale S. Chiara

Trento, 38100, Italy

Location

Ospedale San Isidoro

Trescore Balneario, 24069, Italy

Location

Ospedale General Regional Ca Foncello

Treviso, 31100, Italy

Location

Ospedale Maggiore dell' Universita

Trieste, 34100, Italy

Location

Ospedale Cattinara

Trieste, Italy

Location

Cattedra di Immunologia Clinica

Turin (TO), 10128, Italy

Location

Universita Degli Studi di Udine

Udine, 33100, Italy

Location

Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Ospedale San Bortolo

Vicenza, 36100, Italy

Location

Inha University Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Interferon-alpha; Fluorouracil; Leucovorin; Levamisole

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Thiazoles; Sulfur Compounds; Organic Chemicals; Imidazoles; Azoles

Study Officials

• Francesco Tonelli, MD

  Universita Degli Studi di Florence - Policlinico di Careggi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: November 1, 1991
• Last Updated: September 20, 2013

Record last verified: 2005-11

Locations

KR (1); GR (1); IT (83)