Study of Gamma Interfereon in Metastatic Colorectal Carcinoma (GFL)

Accelerated Community Oncology Research Network

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: Gamma-Interferon-1b (IFN-γ); Drug: Leucovorin (LV); Drug: Bevacizumab; Drug: 5-Fluorouracil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00786643

WITMMCC0301

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Metastatic colorectal cancer, histologically or cytologically confirmed
• Age 18 or greater
• Adequate hematologic function (ANC > 1500, hemoglobin > 10 g/dl, platelet count > 100,000)
• Adequate hepatic parameters (bilirubin < 2.0, Alk. Phos < 5 times normal, ALT < 5 times normal)
• Adequate renal function (creatinine < 2.0)
• Performance status ECOG 0-2
• 0-2 prior lines of chemotherapy for metastatic colorectal cancer are allowed. Prior 5-FU/LV or capecitabine allowed either in the adjuvant setting, or in the metastatic setting or both.
• Absence of other serious concurrent medical illnesses
• Evaluable or measurable disease for phase I; measurable disease only for phase II

Exclusion criteria

• Histologies other than adenocarcinoma
• Previous grade 4 toxicity to 5-FU +/- LV or capecitabine
• Uncontrolled brain metastases
• Chronic diarrhea (greater than five bowel movements per day)
• Previous chemotherapy or radiation therapy less than 4 weeks prior to study day 1 (less than 6 weeks for chemotherapy with Mitomycin or nitrosoureas)
• Major surgery within 2 weeks before study entry
• Known allergic sensitivity to leucovorin
• Prior exposure to IFN-γ
• Previous hematopoietic growth factor (e.g. epoetin alfa or darbepoietin less than 2 weeks prior to study day 1)
• Pregnancy or breast feeding. Women of child-bearing potential must have a negative pregnancy test before the first dose.
• Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ
• Inability to provide written and informed consent
• Uncontrolled hypertension
• History of deep venous thrombosis or CVA
• Prior exposure to bevacizumab
• Proteinuria > 500 mg/24 hr

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

48 participants in 2 patient groups

Stratum 1

Experimental group

Description:

Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.

Treatment:

Drug: Gamma-Interferon-1b (IFN-γ)

Drug: Bevacizumab

Drug: 5-Fluorouracil

Drug: Leucovorin (LV)

Stratum 2

Experimental group

Description:

Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.

Treatment:

Drug: Gamma-Interferon-1b (IFN-γ)

Drug: 5-Fluorouracil

Drug: Leucovorin (LV)