Conditions: Colorectal Cancer
Keywords: Gamma Interferon 5-FU LV
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 48
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Patients in stratum 1 have not received prior chemotherapy in the metastatic setting. arm 2: Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.

Interventions: intervention 1: 5-Fluorouracil intervention 2: Leucovorin (LV) intervention 3: Gamma-Interferon-1b (IFN-γ) intervention 4: Bevacizumab
Intervention descriptions: intervention 1: 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. intervention 2: Leucovorin 200mg/m\^2 was administered over 2 hours on day 1 and day 2 of each cycle. intervention 3: 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. intervention 4: 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.

Protocol document: