Irinotecan Hydrochloride, Fluorouracil, and Leucovorin Calcium With or Without Zibotentan in Treating Patients With Metastatic Colorectal Cancer

Sponsor
Cardiff University
Study ID
NCT01205711
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FOLFIRI regimen — DRUG
  • fluorouracil — DRUG
  • irinotecan hydrochloride — DRUG
  • leucovorin calcium — DRUG
  • zibotentan — DRUG
  • laboratory biomarker analysis — OTHER
  • pharmacogenomic studies — OTHER

Study Details

RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Zibotentan may be effective in treating metastatic colorectal cancer that has not responded to oxaliplatin. It is not yet known whether combination chemotherapy is more effective when given with or without zibotentan in treating metastatic colorectal cancer. PURPOSE: This randomized phase II trial is studying giving irinotecan hydrochloride together with fluorouracil and leucovorin calcium to see how well it works when given with or without zibotentan in treating patients with metastatic colorectal cancer.

Key Dates

Start date
Apr 30, 2010
Status verified
Jul 2014
Primary completion
Jul 31, 2011
Completion
Sep 30, 2012

Study Design

Enrollment
111 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Primary Outcome Measure

Progression-free survival

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