Phase 2 N=48 Treatment

Study of Gamma Interfereon in Metastatic Colorectal Carcinoma

Colorectal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00786643 ↗

Enrolled (actual)

Serious AEs

14.9%

Results posted

Feb 2012

Primary outcome: Primary: Best Response (BR) — 0; 0; 6; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 5-Fluorouracil (Drug); Leucovorin (LV) (Drug); Gamma-Interferon-1b (IFN-γ) (Drug); Bevacizumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Accelerated Community Oncology Research Network
Primary completion: Mar 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Best Response (BR)	0; 0; 6; 3; 7; 15	—
SECONDARY Early Response Rate (RR) (Stratum 1 Only)	0; 5; 7; 6; 2	—
SECONDARY Time to Progression	5.5263; 3.9145	—

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 500 mg/24 hr

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00786643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.