Study of Gamma Interfereon in Metastatic Colorectal Carcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

February 28, 2006

Primary Completion Date

March 31, 2010

Study Completion Date

March 31, 2010

Conditions
Colorectal Cancer
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.

Trial Locations (1)

38120

The West Clinic, Memphis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

InterMune

INDUSTRY

lead

Accelerated Community Oncology Research Network

OTHER

NCT00786643 - Study of Gamma Interfereon in Metastatic Colorectal Carcinoma | Biotech Hunter | Biotech Hunter