A Pilot Trial of GI-4000 Plus Bevacizumab and Either FOLOFOX or FOLFIRI

Colon Cancer Clinical Trial

Official title: A Pilot Trial of GI-4000 Plus Bevacizumab and Either FOLOFOX or FOLFIRI in Patients With Newly Diagnosed Ras Mutant Positive Metastatic Colorectal Cancer or Patients With Ras Mutant Positive Colorectal Cancer Who Have Just Completed a First Line Therapy With an Oxaliplatin or Irinotecan Plus Fluoropyrimidine and Bevacizumab Containing Regimen

Status Terminated

Clinical Trial Summary

The purpose of this study is to test the safety of GI-4000 and see what effects (good and bad) it has against cancer over time. This study is also being done to measure the immune response to GI-4000. Study drug will be given in addition to a standard of care which is a standard therapy given to patients with your type of cancer (colon).

Clinical Trial Description

Subject visits will occur 1-4 weeks prior to initiation of GI-4000, then

• In newly diagnosed (Group A) patients, at every FOLFOX/FOLFIRI plus bevacizumab visit, bevacizumab and GI-4000 dosing visit, GI-4000 dosing visit and then quarterly after completion of therapy

• In patients with stable disease who have completed a first line therapy with an oxaliplatin or irinotecan plus fluoropyrimidine and bevacizumab containing regimen (Group B), at every bevacizumab and GI-4000 dosing visit, GI-4000 dosing visit and then quarterly after completion of therapy

Group A patients (N=26) will be enrolled into the study prior to the initiation of first line therapy with bevacizumab plus either FOLFOX (N=13) or FOLFIRI (N=13)

• Subjects will receive 1 40YU dose of GI-4000 prior to initiation of FOLFOX or FOLFIRI plus bevacizumab, then intercycle doses of GI-4000 will be given 7 days after each cycle while first line therapy is given (up to 8 cycles)

• After completion of first line therapy, subjects will enter the maintenance phase in which bevacizumab and GI-4000 will be given concurrently every 2 weeks for as long as therapy can be tolerated or until progression

• If a subject discontinues bevacizumab therapy due to intolerance, the subject will continue GI-4000 every 2 weeks until progression, intolerance or withdrawal from the study

Group B patients (N=26) with stable disease who have completed a first line therapy with an oxaliplatin or irinotecan plus fluoropyrimidine and bevacizumab containing regimen ) will enter the trial prior to receiving therapy with bevacizumab

• Subjects will receive 40 YU GI-4000 concurrently with each bevacizumab dose for as long as therapy can be tolerated or until progression

• If a subject discontinues bevacizumab therapy due to intolerance, the subject will continue GI-4000 every 2 weeks until progression, intolerance or withdrawal from the study ;

Study Design

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

Related Conditions & MeSH terms

• Colon Cancer

• NCT number: NCT01322815
• Study type: Interventional
• Source: Georgetown University
• Status: Terminated
• Phase: Phase 2
• Start date: October 2010
• Completion date: December 2015