Study of Gamma Interfereon in Metastatic Colorectal Carcinoma
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: 5-Fluorouracil; Leucovorin (LV); Gamma-Interferon-1b (IFN-γ); Bevacizumab
Intervention description: 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.; Leucovorin 200mg/m^2 was administered over 2 hours on day 1 and day 2 of each cycle.; 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.; 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.
Intervention MeSH terms: Leucovorin; Interferons; Interferon-gamma; Bevacizumab; Fluorouracil; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gamma Interferon; 5-FU; LV

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.
    

Eligibility 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