Study of Gamma Interfereon in Metastatic Colorectal Carcinoma

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Accelerated Community Oncology Research Network
• Collaborator: InterMune
• Treatments: Bevacizumab; Fluorouracil; Interferon-gamma; Interferons; Leucovorin; Levoleucovorin

Criteria

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