| Phase III Adjuvant Study of Levamisole vs Alfa Interferon 2a Plus Fluorouracil and Leucovorin Calcium for Intraperitoneal Colorectal Cancer
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Alternate Title
Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer
Basic Trial Information
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Phase III
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Closed
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75 and under
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CNR-TONE-01
EU-97011, NCT00003063
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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.
Entry 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
Prior/Concurrent Therapy:
Biologic therapy - No prior immunotherapy for the current cancer
Chemotherapy - No prior chemotherapy for the current cancer
Endocrine therapy Radiotherapy - No prior radiotherapy for the current cancer
Surgery Patient Characteristics:
Age: Performance status: Life expectancy: 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
Expected Enrollment 1050350 patients per arm will be accrued for a total of 1,050 patients. 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.
Trial Contact Information
Trial Lead Organizations European Institute of Oncology | | | | Francesco Tonelli, MD, Protocol chair | | | |
| Registry Information | | | Official Title | | Adjuvant Chemoimmunotherapy for Colorectal Cancer | | | Trial Start Date | | 1991-11-15 | | | Registered in ClinicalTrials.gov | | NCT00003063 | | | Date Submitted to PDQ | | 1997-08-18 | | | Information Last Verified | | 2005-11-22 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
