- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00786643
Study of Gamma Interfereon in Metastatic Colorectal Carcinoma (GFL)
February 28, 2012 updated by: Accelerated Community Oncology Research Network
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Tennessee
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Memphis, Tennessee, United States, 38120
- The West Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stratum 1
Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
|
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:
Leucovorin 200mg/m^2 was administered over 2 hours on day 1 and day 2 of each cycle.
Other Names:
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:
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 Names:
|
Experimental: Stratum 2
Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
|
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:
Leucovorin 200mg/m^2 was administered over 2 hours on day 1 and day 2 of each cycle.
Other Names:
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best Response (BR)
Time Frame: After every 4 cycles of treatment (approximately every 56 days for up to about 280 days)
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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.
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After every 4 cycles of treatment (approximately every 56 days for up to about 280 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Early Response Rate (RR) (Stratum 1 Only)
Time Frame: After 4 cycles of treatment (approximately 56 days)
|
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.
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After 4 cycles of treatment (approximately 56 days)
|
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
|
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.
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Lee Schwartzberg, MD, Vector Oncology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
November 3, 2008
First Submitted That Met QC Criteria
November 5, 2008
First Posted (Estimate)
November 6, 2008
Study Record Updates
Last Update Posted (Estimate)
March 1, 2012
Last Update Submitted That Met QC Criteria
February 28, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Micronutrients
- Vitamins
- Antidotes
- Vitamin B Complex
- Interferons
- Fluorouracil
- Bevacizumab
- Leucovorin
- Levoleucovorin
- Interferon-gamma
Other Study ID Numbers
- WITMMCC0301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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