Clinical trial NCT00786643: Study of Gamma Interfereon in Metastatic Colorectal Carcinoma
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: Gamma Interferon
5-FU
LV
Lead sponsor: Accelerated Community Oncology Research Network
Sponsor class: OTHER
Collaborators: name: InterMune
First posted: 2008-11-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Best Response (BR)
timeFrame: After every 4 cycles of treatment (approximately every 56 days for up to about 280 days)
Secondary outcomes:
measure: Early Response Rate (RR) (Stratum 1 Only)
timeFrame: After 4 cycles of treatment (approximately 56 days)
measure: Time to Progression
timeFrame: 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
Other outcomes:
Locations:
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
Study officials:
affiliation: Vector Oncology
name: Lee Schwartzberg, MD
role: STUDY_CHAIR
References: