Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
European Institute of Oncology
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003063
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: November 2005
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Adjuvant Chemoimmunotherapy for Colorectal Cancer |
Resource links provided by NLM:
Drug Information available for:
Fluorouracil
Leucovorin calcium
Interferon
Levoleucovorin
Interferon Alfa-2a
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
| Estimated Enrollment: | 1050 |
| Study Start Date: | November 1991 |
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
Hide Study Locations
Hide Study LocationsLocations
| Greece | |
| George Papanicolaou General Hospital | |
| Thessaloniki, Greece, 57010 | |
| Italy | |
| Ospedale Bassini | |
| Balsamo Cinisello, Italy, 20092 | |
| Universita Degli Studi di Bari Policlinico | |
| Bari, Italy, 70124 | |
| Spedali Civili | |
| Brescia, Italy, 25124 | |
| Ospedale San Michele | |
| Cagliari, Italy, 9100 | |
| Cattedra di Oncologia Medica - Universita | |
| Cagliari, Italy, 09124 | |
| Ospedale Oncologico A. Businco | |
| Cagliari, Italy, 09124 | |
| Ospedale Valduce | |
| Como, Italy, 22100 | |
| Ospedale Sant Anna | |
| 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 | |
| U.S.L. 10 Villa Ognissanti | |
| Firenze, Italy, 50139 | |
| Policlinico di Careggi | |
| Firenze (Florence), Italy, 50134 | |
| Universita Degli Studi di Firenze - Policlin. di Careggi | |
| Firenze (Florence), Italy, 1 (50134) | |
| 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 | |
| Istituto Scientifico H.S. Raffaele | |
| Milano, Italy, 20132 | |
| Casa Di Cura San Ambrogio | |
| Milano, Italy, 20149 | |
| Consorzio Provinciale Antitubercolare | |
| Milano, Italy, 20124 | |
| Ospedale San Giuseppe | |
| Milano, Italy, 20100 | |
| Istituto Di Science Biomediche San Paolo | |
| Milano, Italy, 20142 | |
| Ospedale San Carlo Borromeo | |
| Milano (Milan), Italy, 20153 | |
| Ospedale Luigi Sacco | |
| Milano (Milan), Italy, 20157 | |
| Ospedale Maggiore Ca Granda | |
| Milano (Milan), Italy, 20162 | |
| Ospedale Santa Croce | |
| Moncalieri, Italy, 10024 | |
| Nuovo Ospedale San Gerardo | |
| Monza, Italy, 20052 | |
| Ospedale Civile Asilo Vittoria | |
| Mortara, Italy, 27036 | |
| Istituto Nazionale per lo Studio e la Cura dei Tumori | |
| Naples, Italy, 80131 | |
| Istituto Tumori/Fondazione Pascale | |
| Naples (Napoli), Italy, 80131 | |
| Federico II University Medical School | |
| Naples (Napoli), 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 Torrette University Ancona | |
| Parma, Italy, 43100 | |
| Ospedale Maggiore Parma | |
| 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 S. Camillo-Forlanini | |
| Rome, Italy, 00151 | |
| Ospedale San Filippo Neri | |
| Rome, Italy, 00135 | |
| Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore | |
| Rome, Italy, 00168 | |
| Ospedale Carlo Forlanini | |
| Rome, Italy, 00149 | |
| Azienda Policlinico Umberto Primo | |
| Rome, Italy, 00161 | |
| 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
Investigators
| Study Chair: | Francesco Tonelli, MD | Universita Degli Studi di Florence - Policlinico di Careggi |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00003063 History of Changes |
| Other Study ID Numbers: | CDR0000065728, CNR-TONE-01, EU-97011 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| 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:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Interferon-alpha Interferon Alfa-2a Interferons Fluorouracil |
Levamisole Leucovorin Levoleucovorin Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Antimetabolites |
ClinicalTrials.gov processed this record on June 18, 2013