Phase 2 Completed N=48 Treatment

Study of Gamma Interfereon in Metastatic Colorectal Carcinoma

Colorectal Cancer

Source: ClinicalTrials.gov NCT00786643 ↗

Enrolled (actual)

Serious AEs

14.9%

Results posted

Feb 2012

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

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.

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	—

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

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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. Informational only — not medical advice.