Sunitinib Malate and Combination Chemotherapy as Front-Line Therapy in Treating Patients With Metastatic Rectal Cancer That Cannot Be Removed by Surgery

Sponsor
Federation Francophone de Cancerologie Digestive
Study ID
NCT00936832
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • FOLFIRI regimen — DRUG
  • fluorouracil — DRUG
  • irinotecan hydrochloride — DRUG
  • leucovorin calcium — DRUG
  • sunitinib malate — DRUG
  • laboratory biomarker analysis — OTHER
  • pharmacogenomic studies — OTHER
  • pharmacological study — OTHER

Study Details

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with sunitinib malate may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving sunitinib malate together with combination chemotherapy works as front-line therapy in treating patients with metastatic rectal cancer that cannot be removed by surgery.

Key Dates

Start date
Apr 30, 2009
Status verified
Jul 2009
Primary completion
Mar 24, 2010
Completion
Mar 24, 2010

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT

Primary Outcome Measure

Response rate at 3 months as assessed by RECIST criteria

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