Study of Gamma Interfereon in Metastatic Colorectal Carcinoma

NCT ID: NCT00786643

Last Updated: 2012-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2010-03-31

Brief 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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stratum 1

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

Group Type: EXPERIMENTAL

5-Fluorouracil

Intervention Type: DRUG

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 (LV)

Intervention Type: DRUG

Leucovorin 200mg/m\^2 was administered over 2 hours on day 1 and day 2 of each cycle.

Gamma-Interferon-1b (IFN-γ)

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Stratum 2

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

Group Type: EXPERIMENTAL

5-Fluorouracil

Intervention Type: DRUG

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 (LV)

Intervention Type: DRUG

Leucovorin 200mg/m\^2 was administered over 2 hours on day 1 and day 2 of each cycle.

Gamma-Interferon-1b (IFN-γ)

Intervention Type: DRUG

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.

Interventions

5-Fluorouracil

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.

Intervention Type: DRUG

Leucovorin (LV)

Leucovorin 200mg/m\^2 was administered over 2 hours on day 1 and day 2 of each cycle.

Intervention Type: DRUG

Gamma-Interferon-1b (IFN-γ)

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.

Intervention Type: DRUG

Bevacizumab

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 Type: DRUG

Other Intervention Names

Fluororacil; 5-FU; leucovorin calcium; folinic acid; Gamma-Interferon-1b; Gamma-Interferon; Actimmune; Avastin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InterMune

INDUSTRY

Sponsor Role: collaborator

Accelerated Community Oncology Research Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lee Schwartzberg, MD

Role: STUDY_CHAIR

Vector Oncology

Locations

The West Clinic

Memphis, Tennessee, United States

Countries

United States

Other Identifiers

WITMMCC0301

Identifier Type: -

Identifier Source: org_study_id