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Study of Xeloda and Gleevec in Patients With Advanced Solid Tumors

NCT00183833 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-05-22

No results posted yet for this study

Summary

This study is for people with solid tumors cancer for which the standard chemotherapy drugs have not worked. The purpose of this research is to evaluate the side effects of Xeloda (also called capecitabine) in combination with a new anticancer agent called Gleevec (also called imatinib mesylate). Xeloda is an anticancer drug, and can be taken by mouth. The active ingredient is a well-studied cancer drug called 5-FU. Xeloda is approved by the FDA for the treatment of colon cancer. Gleevec is approved in the US for the treatment of patients with a leukemia called CML (increase of white blood cells) after failure of standard therapy. It is also approved by the FDA for patients with Gastrointestinal Stromal Tumors (a rare tumor in the digestive tract).

This study will test how much Gleevec we can safely give with Xeloda. Xeloda will be given at the recommended dose for colorectal cancer and Gleevec will be given in increasing amounts.

Conditions

Interventions

DRUG

capecitabine, imatinib mesylate

Capecitabine and imatinib mesylate will both be taken by mouth twice a day

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • University of Southern California

    lead OTHER

Principal Investigators

  • Heinz-Josef Lenz, M.D. · U.S.C./Norris 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
2002-12-31
Primary Completion
2009-07-31
Completion
2010-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00183833 on ClinicalTrials.gov