CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
5-Fluorouracil +3 moredrug
Likely dose
5-Fluorouracil 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00786643
NCT00786643Phase 2Completed
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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

Accelerated Community Oncology Research Network·interventional·Posted Nov 6, 2008·Updated Mar 1, 2012

In Brief

A Phase 2 clinical trial evaluating 5-Fluorouracil, Leucovorin (LV), and 2 other interventions for Colorectal Cancer. Completed, enrolled 48 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer
CountriesUnited States
CollaboratorsInterMune

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 6, 2008
Enrollment StartFeb 1, 2006
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 17.7 years ago

Interventions

5-Fluorouracildrug

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.

Leucovorin (LV)drug

Leucovorin 200mg/m\^2 was administered over 2 hours on day 1 and day 2 of each cycle.

Gamma-Interferon-1b (IFN-γ)drug

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.

Bevacizumabdrug

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.