Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Adjuvant Chemoimmunotherapy for Colorectal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00003063
• Other study ID #: CDR0000065728
• Secondary ID: CNR-TONE-01EU-97
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: September 19, 2013
• Start date: November 1991

Study information

• Verified date: November 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1050
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Biological:
• recombinant interferon alfa

Drug:
• fluorouracil

• leucovorin calcium

• levamisole hydrochloride

Locations

Country	Name	City	State
Greece	George Papanicolaou General Hospital	Thessaloniki
Italy	Ospedale Bassini	Balsamo Cinisello
Italy	Universita Degli Studi di Bari Policlinico	Bari
Italy	Spedali Civili	Brescia
Italy	Cattedra di Oncologia Medica - Universita	Cagliari
Italy	Ospedale Oncologico A. Businco	Cagliari
Italy	Ospedale San Michele	Cagliari
Italy	Ospedale Sant Anna	Como
Italy	Ospedale Valduce	Como
Italy	Ospedale Di Conselice	Conselice
Italy	Ospedale Civile Cosenza	Cosenza
Italy	Ospedale Maggiore Crema	Crema
Italy	Ospedale Santa Croce	Cuneo
Italy	Ospedale Civile Feltre	Feltre
Italy	Universita di Ferrara	Ferrara
Italy	U.S.L. 10 Villa Ognissanti	Firenze
Italy	Policlinico di Careggi	Firenze (Florence)
Italy	Universita Degli Studi di Firenze - Policlin. di Careggi	Firenze (Florence)
Italy	Istituto Nazionale per la Ricerca sul Cancro	Genoa (Genova)
Italy	Ospedale San Martino/Cliniche Universitarie Convenzionate	Genoa (Genova)
Italy	Ospedale Galliera Oncologia	Genova (Genoa)
Italy	Ospedale Di Gorgonzola	Gorgonzola
Italy	Ospedale Legnago USSL 21	Legnago
Italy	Ospedale Maggiore Lodi	Lodi
Italy	Ospedale Umberto I	Lugo DI Romagna
Italy	U.S.S.L. 72 Magenta	Magenta
Italy	Carlo Poma Hospital	Mantova
Italy	Ospedale Di Predabissi Melegnano	Melegnano
Italy	Azienda USSL NO 8	Merate
Italy	Instituto Di Oncologia	Messina
Italy	Ospedale Civile Umberto I	Mestre
Italy	Casa Di Cura San Ambrogio	Milano
Italy	Consorzio Provinciale Antitubercolare	Milano
Italy	Istituto Di Science Biomediche San Paolo	Milano
Italy	Istituto Scientifico H.S. Raffaele	Milano
Italy	Ospedale San Giuseppe	Milano
Italy	Ospedale Luigi Sacco	Milano (Milan)
Italy	Ospedale Maggiore Ca Granda	Milano (Milan)
Italy	Ospedale San Carlo Borromeo	Milano (Milan)
Italy	Ospedale Santa Croce	Moncalieri
Italy	Nuovo Ospedale San Gerardo	Monza
Italy	Ospedale Civile Asilo Vittoria	Mortara
Italy	Istituto Nazionale per lo Studio e la Cura dei Tumori	Naples
Italy	Federico II University Medical School	Naples (Napoli)
Italy	Istituto Tumori/Fondazione Pascale	Naples (Napoli)
Italy	Ospedale C. Ascalesi	Napoli
Italy	Ospedale Vincenzo Monaldi	Napoli
Italy	Ospedale Civile Negrar	Negrar
Italy	Azienda Ospedaliera di Padova	Padova (Padua)
Italy	University of Padua	Padua
Italy	Ospedale Civico E Benefratelli	Palermo
Italy	Ospedale Maggiore Parma	Parma
Italy	Ospedale Torrette University Ancona	Parma
Italy	Ospedale Silvestrini	Perugia
Italy	Ospedale Agnelli	Pinerolo
Italy	Ospedale Sta. Maria Delle Croci	Ravenna
Italy	Azienda Ospedaliera	Reggio Emilia
Italy	Ospedale Civile Rho	Rho
Italy	Azienda Policlinico Umberto Primo	Rome
Italy	Istituti Fisioterapici Ospitalieri - Roma	Rome
Italy	Ospedale Carlo Forlanini	Rome
Italy	Ospedale S. Camillo-Forlanini	Rome
Italy	Ospedale San Filippo Neri	Rome
Italy	Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore	Rome
Italy	Policlinico Militare Celio	Rome
Italy	ASL NO. 1 Imperiese	San Remo
Italy	Azienda USSL No 4	Saronno
Italy	Istituto Clinica Medica	Sassari
Italy	Ospedale S.S. Annunziata	Savigliano
Italy	Ospedale Sesto San Giovanni	Sesto San Giovanni
Italy	Azienda Ospedaliera S. Maria	Terni
Italy	Ospedale Generale Prov. Boldrini	Thiene
Italy	Dispensario Igiene Sociale	Toino
Italy	Clinica Universita	Torino
Italy	Universita Torino	Torino
Italy	Ospedale S. Chiara	Trento
Italy	Ospedale San Isidoro	Trescore Balneario
Italy	Ospedale General Regional Ca Foncello	Treviso
Italy	Ospedale Cattinara	Trieste
Italy	Ospedale Maggiore dell' Universita	Trieste
Italy	Cattedra di Immunologia Clinica	Turin (TO)
Italy	Universita Degli Studi di Udine	Udine
Italy	Ospedale di Circolo e Fondazione Macchi	Varese
Italy	Ospedale San Bortolo	Vicenza
Korea, Republic of	Inha University Hospital	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Countries where clinical trial is conducted

Greece,  Italy,  Korea, Republic of,