Clinical trial NCT00003063: Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer
Official title: Adjuvant Chemoimmunotherapy for Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: stage II colon cancer
stage III colon cancer
stage II rectal cancer
stage III rectal cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 1050
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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 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

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