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Study of Gamma Interfereon in Metastatic Colorectal Carcinoma (GFL)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
5-Fluorouracil
Leucovorin (LV)
Gamma-Interferon-1b (IFN-γ)
Bevacizumab
Sponsored by
Accelerated Community Oncology Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Gamma Interferon, 5-FU, LV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The West Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stratum 1

Stratum 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Best Response (BR)
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.

Secondary Outcome Measures

Early Response Rate (RR) (Stratum 1 Only)
Early RR evaluated in stratum 1 to see if bevacizumab (bev) would be added to GFL treatment (tx). Patients with stable disease (SD) pre 5th cycle of tx had bev added. Response was evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Per RECIST and CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of longest diameter (LD) of target lesions; SD, neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD), increase in existing lesions or new lesions.
Time to Progression
Patients were censored if they did not progress, stopped particiaption due to an adverse event, or withdrew consent following the start of study treatment. Response was evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.0. Per RECIST v1.0, Progressive Disease (PD) is defined as a measurable increase in smallest diameter of any target or non-target lesion, or the appearance of new lesions, since baseline.

Full Information

First Posted
November 3, 2008
Last Updated
February 28, 2012
Sponsor
Accelerated Community Oncology Research Network
Collaborators
InterMune
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1. Study Identification

Unique Protocol Identification Number
NCT00786643
Brief Title
Study of Gamma Interfereon in Metastatic Colorectal Carcinoma
Acronym
GFL
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Accelerated Community Oncology Research Network
Collaborators
InterMune

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Gamma Interferon, 5-FU, LV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stratum 1
Arm Type
Experimental
Arm Description
Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
Arm Title
Stratum 2
Arm Type
Experimental
Arm Description
Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil
Other Intervention Name(s)
Fluororacil, 5-FU
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.
Intervention Type
Drug
Intervention Name(s)
Leucovorin (LV)
Other Intervention Name(s)
leucovorin calcium, folinic acid
Intervention Description
Leucovorin 200mg/m^2 was administered over 2 hours on day 1 and day 2 of each cycle.
Intervention Type
Drug
Intervention Name(s)
Gamma-Interferon-1b (IFN-γ)
Other Intervention Name(s)
Gamma-Interferon-1b, Gamma-Interferon, Actimmune
Intervention Description
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
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Best Response (BR)
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.
Time Frame
After every 4 cycles of treatment (approximately every 56 days for up to about 280 days)
Secondary Outcome Measure Information:
Title
Early Response Rate (RR) (Stratum 1 Only)
Description
Early RR evaluated in stratum 1 to see if bevacizumab (bev) would be added to GFL treatment (tx). Patients with stable disease (SD) pre 5th cycle of tx had bev added. Response was evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Per RECIST and CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of longest diameter (LD) of target lesions; SD, neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD), increase in existing lesions or new lesions.
Time Frame
After 4 cycles of treatment (approximately 56 days)
Title
Time to Progression
Description
Patients were censored if they did not progress, stopped particiaption due to an adverse event, or withdrew consent following the start of study treatment. Response was evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.0. Per RECIST v1.0, Progressive Disease (PD) is defined as a measurable increase in smallest diameter of any target or non-target lesion, or the appearance of new lesions, since baseline.
Time Frame
From date of study treatment start until date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Schwartzberg, MD
Organizational Affiliation
Vector Oncology
Official's Role
Study Chair
Facility Information:
Facility Name
The West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States

12. IPD Sharing Statement

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Study of Gamma Interfereon in Metastatic Colorectal Carcinoma

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