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FOLFOX Chemotherapy Regimen (5-FU, Leucovorin, Oxaliplatin) in Metastatic Colorectal Cancer

NCT00501410 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2019-08-28

No results posted yet for this study

Summary

The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of a combination of dasatinib, cetuximab, and FOLFOX (5-fluorouracil \[5-FU\], leucovorin \[LV\], and Eloxatin \[oxaliplatin\]) that can be given to patients with metastatic colorectal cancer. The safety of these drugs in combination will also be studied.

The goal of the Phase II part of this clinical research study is to learn if dasatinib given in combination with FOLFOX with or without cetuximab can help to control metastatic colorectal cancer.

Conditions

Interventions

DRUG

5-FU

2400 mg/m\^2 by vein over 46 Hours On Days 1 \& 2.

DRUG

Cetuximab

Initial Dose = 400 mg/m\^2 by vein, then 250 mg/m\^2 Weekly On Days 1 \& 8

DRUG

Dasatinib

Starting dose level: 100 mg by mouth daily on days 1-14.

DRUG

Leucovorin

400 mg/m\^2 by vein on day 1.

DRUG

Oxaliplatin

85 mg/m\^2 by vein on day 1.

Sponsors & Collaborators

Principal Investigators

  • Scott Kopetz, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-23
Primary Completion
2017-03-03
Completion
2017-03-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT00501410 on ClinicalTrials.gov