NCT00786643

Study of Gamma Interfereon in Metastatic Colorectal Carcinoma

Phase II Study of Gamma Interferon (IFN-γ) Added to Bolus + Infusional 5-Fluorouracil (5-FU) and Leucovorin (LV) +/- Bevacizumab (BV) in Metastatic Colorectal Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Accelerated Community Oncology Research Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evalute the response and toxicity of metastatic colorectal cancer patients to the regimen of gamma interferon added to bolus and infusional 5-fluorouracil and leucovorin (GFL) with or without bevacizumab.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	5-Fluorouracil	5-FU bolus was administered at 400mg/m\^2 on day 1 and day 2 of each cycle. 5-FU at 600 mg/m\^2 infusion was administered over 22 hours on day 1 and day 2 of each cycle.
DRUG	Leucovorin (LV)	Leucovorin 200mg/m\^2 was administered over 2 hours on day 1 and day 2 of each cycle.
DRUG	Gamma-Interferon-1b (IFN-γ)	Gamma-Interferon 150 mcg/m\^2 was administered by subcutaneous injection on day 1 of each cycle immediately before treatment with 5-FU and LV, and on day 3 of each cycle immediately after treatment with 5-FU and LV.
DRUG	Bevacizumab	Bevacizumab 5mg/kg was only added to the treatment regimen of patients in stratum 1 who demonstrated stable disease on imaging repeated prior to the 5th cycle of treatment. Bavacizumab was administered on day 4 of each cycle.

Timeline

• Start date: 2006-02-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2008-11-06
• Last updated: 2012-03-01
• Results posted: 2012-02-22

Locations

1 site across 1 country: United States