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Study of Gamma Interfereon in Metastatic Colorectal Carcinoma (GFL)

This study has been completed.
Sponsor:
Collaborator:
InterMune
Information provided by (Responsible Party):
Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier:
NCT00786643
First received: November 3, 2008
Last updated: February 28, 2012
Last verified: February 2012
History of Changes
  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.


Condition Intervention Phase
Colorectal Cancer
 Drug: 5-Fluorouracil
Drug: Leucovorin (LV)
Drug: Gamma-Interferon-1b (IFN-γ)
Drug: Bevacizumab
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Accelerated Community Oncology Research Network:

Primary Outcome Measures:
  • Best Response (BR) [ Time Frame: After every 4 cycles of treatment (approximately every 56 days for up to about 280 days) ] [ Designated as safety issue: No ]
    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) [ Time Frame: After 4 cycles of treatment (approximately 56 days) ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 48
Study Start Date: February 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stratum 1
Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
 Drug: 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.
Other Names:
  • Fluororacil
  • 5-FU
Drug: Leucovorin (LV)
Leucovorin 200mg/m^2 was administered over 2 hours on day 1 and day 2 of each cycle.
Other Names:
  • leucovorin calcium
  • folinic acid
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.
Other Names:
  • Gamma-Interferon-1b
  • Gamma-Interferon
  • Actimmune
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.
Other Name: Avastin
Experimental: Stratum 2
Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
 Drug: 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.
Other Names:
  • Fluororacil
  • 5-FU
Drug: Leucovorin (LV)
Leucovorin 200mg/m^2 was administered over 2 hours on day 1 and day 2 of each cycle.
Other Names:
  • leucovorin calcium
  • folinic acid
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.
Other Names:
  • Gamma-Interferon-1b
  • Gamma-Interferon
  • Actimmune

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786643

Locations
United States, Tennessee
The West Clinic
Memphis, Tennessee, United States, 38120
Sponsors and Collaborators
Accelerated Community Oncology Research Network
InterMune
Investigators
Study Chair: Lee Schwartzberg, MD ACORN Research, LLC
  More Information

No publications provided

Responsible Party: Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier: NCT00786643     History of Changes
Other Study ID Numbers: WITMMCC0301
Study First Received: November 3, 2008
Results First Received: November 17, 2011
Last Updated: February 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Accelerated Community Oncology Research Network:
Gamma Interferon
5-FU
LV

Additional relevant MeSH terms:
Carcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
 Bevacizumab
Interferons
Interferon-gamma
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents

ClinicalTrials.gov processed this record on May 16, 2013