Expired Study
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Memphis, Tennessee 38120


Purpose:

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.


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


NCT ID:

NCT00786643


Primary Contact:

Study Chair
Lee Schwartzberg, MD
ACORN Research, LLC


Backup Contact:

N/A


Location Contact:

Memphis, Tennessee 38120
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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