Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy

Recruiting in Palo Alto (17 mi)

+144 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This randomized phase II trial is studying how well pemetrexed disodium or observation works in treating patients with malignant pleural mesothelioma without progressive disease after first-line chemotherapy.

Eligibility Criteria

Inclusion Criteria

Epithelial

Sarcomatoid

Mixed type

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Treatment Details

Interventions

Clinical Observation (Other)
Pemetrexed Disodium (Anti-metabolites)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm IExperimental Treatment1 Intervention

Patients receive pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm IIActive Control1 Intervention

Patients undergo observation until disease progression.