NCT01183494

A Genotype-guided Study of Irinotecan Administered in Combination With 5-fluorouracil/Leucovorin (FOLFIRI) and Bevacizumab in Advanced Colorectal Cancer Patients

Completed Phase 1 Last updated 22 April 2019

What this trial tests

Phase 1 trial testing FOLFIRI, Avastin, Irinotecan in Metastatic Colorectal Cancer in 17 participants. Completed in 2 June 2017.

Timeline

12 December 2009

Primary endpoint
2 June 2017

2 June 2017

Quick facts

Lead sponsor	University of Chicago
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	17
Start date	12 December 2009
Primary completion	2 June 2017
Estimated completion	2 June 2017
Sites	2 locations across Italy, United States

Drugs / interventions tested

• FOLFIRI, Avastin, Irinotecan — full drug profile →

Conditions studied

• Metastatic Colorectal Cancer — all drugs for Metastatic Colorectal Cancer →

Sponsor

University of Chicago

Who can join

18 and older, any sex, with Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is being done to determine the maximum dose of a certain chemotherapy drug (irinotecan) that can be tolerated as part of a combination of drugs. There is a combination of chemotherapy drugs typically used to treat cancer of the colon and rectum: 5-Flurouracil (5-FU), leucovorin, and irinotecan; the combination is known as FOLFIRI. At the present time, the Food and Drug Administration (FDA) has approved this drug combination for the treatment of cancers of the colon and rectum. The FDA has also approved the use of a drug called bevacizumab (or Avastin) in combination with FOLFIRI, and this is considered one of the standards of care for all patients with colon and rectal cancer which has spread.

The best dose of irinotecan to use in the combination of FOLFIRI and bevacizumab is not known. Earlier studies have shown that higher doses of irinotecan can be used safely as part of the FOLFIRI combination, but it is unclear whether these same doses will be safe when bevacizumab is added to this combination.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Exceptional Chemotherapy Response in Metastatic Colorectal Cancer Associated With Hyper-Indel-Hypermutated Cancer Genome and Comutation of <i>POLD1</i> and <i>MLH1</i>.
   Sharma MR, Auman JT, Patel NM, Grilley-Olson JE, et al · · 2017 · cited 5× · PMID 30009279 · DOI 10.1200/po.16.00015