Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer

Phase 3

• Conditions: Colorectal Cancer

• Registration Number: NCT00003063
• Lead Sponsor: European Institute of Oncology

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.

Study Timeline

• Study Start: 1991-11
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2005-11
• Last Update Submitted: 2013-09-19
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1050

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (84)

George Papanicolaou General Hospital; 🇬🇷 Thessaloniki, Greece

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

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