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Phase II Study of Gamma Interferon (IFN-γ) Added to Bolus + Infusional 5-Fluorouracil (5-FU) and Leucovorin (LV) +/- Bevacizumab (BV) in Metastatic Colorectal Carcinoma

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

Phase II Study of Gamma Interferon (IFN-γ) Added to Bolus + Infusional 5-Fluorouracil (5-FU) and Leucovorin (LV) +/- Bevacizumab (BV) in Metastatic Colorectal Carcinoma

Inclusion Criteria:

- Metastatic colorectal cancer, histologically or cytologically confirmed

- Age 18 or greater

- Adequate hematologic function (ANC > 1500, hemoglobin > 10 g/dl, platelet count >

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best Response (BR)

Outcome Description:

BR is recorded from start of treatment until progressive disease (PD). Imaging was repeated by same technique after every 4 cycles of treatment. Response was evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.0. Per RECIST v1.0 and CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; PD, increase in existing lesions or new lesions.

Outcome Time Frame:

After every 4 cycles of treatment (approximately every 56 days for up to about 280 days)

Safety Issue:


Principal Investigator

Lee Schwartzberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

ACORN Research, LLC


United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

March 2010

Related Keywords:

  • Colorectal Cancer
  • Gamma Interferon
  • 5-FU
  • LV
  • Carcinoma
  • Colorectal Neoplasms



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