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Study of Gamma Interfereon in Metastatic Colorectal Carcinoma

NCT00786643 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2012-03-01

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • InterMune

    collaborator INDUSTRY

  • Accelerated Community Oncology Research Network

    lead OTHER

Principal Investigators

  • Lee Schwartzberg, MD · Vector Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00786643 on ClinicalTrials.gov