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

NCT00936832 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-08-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

FOLFIRI regimen

DRUG

fluorouracil

DRUG

irinotecan hydrochloride

DRUG

leucovorin calcium

DRUG

sunitinib malate

OTHER

laboratory biomarker analysis

OTHER

pharmacogenomic studies

OTHER

pharmacological study

Sponsors & Collaborators

  • Federation Francophone de Cancerologie Digestive

    lead OTHER

Principal Investigators

  • Philippe Rougier, MD · Hopital Ambroise Pare

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-03-24
Completion
2010-03-24

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00936832 on ClinicalTrials.gov