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SU011248 in Combination With Irinotecan and Cetuximab as a Second Line Regimen for Stage IV Colorectal Cancer

NCT00361244 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2017-02-17

No results posted yet for this study

Summary

The purpose of this study is to determine the safety of SU011248 and the highest dose of this drug that can be given safely in combination with the chemotherapy drugs irinotecan and cetuximab. Laboratory studies have shown that SU011248 may block the growth of blood vessels in tumors, which may prevent tumors from growing any further. Other studies have demonstrated the possibility that SU011248 may enhance the anti-tumor activity of other chemotherapy drugs such as irinotecan and cetuximab.

Conditions

  • Colorectal Carcinoma

Interventions

DRUG

SU011248

Given orally in the morning for two weeks followed by a one week rest period (one cycle equals 21 days). Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side effects.

DRUG

Irinotecan

Given intravenously on days 1 and 8 of each 21-day cycle. Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side effects.

DRUG

Cetuximab

Given intravenously on days 8 and 15 of each 21-day cycle. Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side effects.

Sponsors & Collaborators

Principal Investigators

  • Andrew X. Zhu, MD · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2007-10-31
Completion
2010-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00361244 on ClinicalTrials.gov