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Cisplatin, Pemetrexed, and Imatinib Mesylate in Malignant Mesothelioma

NCT00402766 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2015-11-18

No results posted yet for this study

Summary

Primary Objective:

* To determine the maximum tolerated dose of the combination of cisplatin, imatinib mesylate, and pemetrexed in metastatic malignant mesothelioma.

Secondary Objectives:

* To explore the biologic effects of cisplatin, imatinib mesylate, and pemetrexed on tumor tissue by:
* histologic analysis of biopsy tissue
* by non-invasive assessments of tumor vascularity performed before, during and after treatment
* electron microscopy analysis of endothelial cell architecture after patient treatment with imatinib mesylate
* To explore the effects of cisplatin, imatinib mesylate, and pemetrexed on surrogate markers in serum.
* To assess the rate of response to therapy.
* To determine the doses of the combination regimen of cisplatin, imatinib mesylate, and pemetrexed that enables de-phosphorylation of platelet derived growth factor receptor (PDGF-R) on malignant mesothelioma tumor cells.
* To determine the pharmacokinetic interaction between agents in this combination regimen.

Conditions

Interventions

DRUG

Cisplatin

Starting Dose: 60 mg/m\^2 by vein, Over 2 Hours

DRUG

Imatinib Mesylate

Starting Dose: 300 mg PO Daily

DRUG

Pemetrexed

Starting Dose: 500 mg/m\^2 by vein, Over 40 Minutes

DRUG

Dexamethasone

20 mg by vein given prior to Pemetrexed therapy and 4 mg given orally on Day 2 of each cycle.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Anne S. Tsao, 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
2006-08-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

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Diseases
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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 NCT00402766 on ClinicalTrials.gov