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Imatinib in Combination With Dacarbazine and Capecitabine in Medullary Thyroid Carcinoma

NCT00354523 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2014-12-17

No results posted yet for this study

Summary

Objectives:

Primary objectives:

To determine the maximum tolerated doses (MTD) for the combination of imatinib mesylate, capecitabine, and dacarbazine in patients with solid tumors.

To determine the overall tumor response rate to imatinib mesylate in combination with capecitabine and dacarbazine as first line and second line therapy in advanced metastatic medullary thyroid carcinoma.

To determine the tolerability (toxicity) of this regimen.

Secondary objectives:

To determine the median overall survival (OS) and time to progression (TTP) for patients treated with this combination.

Conditions

Interventions

DRUG

Capecitabine (Xeloda)

Starting Dose 500 mg/m\^2 twice a day Days 1-14 of 21 Day Cycle.

DRUG

DTIC-Dome (Dacarbazine)

Starting Dose 250 mg/m\^2 a day on Days 1-3 of 21 Day Cycle.

DRUG

Gleevec (Imatinib Mesylate)

Starting Dose 400 mg a day on Days 1-21 of 21 Day Cycle.

Sponsors & Collaborators

Principal Investigators

  • James Yao, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2006-11-30
Completion
2013-08-31

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 NCT00354523 on ClinicalTrials.gov