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Pemetrexed Disodium or Observation in Treating Patients With Malignant Pleural Mesothelioma Without Progressive Disease After First-Line Chemotherapy

2014-08-27 03:15:17 | BioPortfolio

Summary

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.

Description

OBJECTIVES:

Primary

- To determine if maintenance therapy with pemetrexed disodium versus observation improves progression-free survival of patients with malignant pleural mesothelioma who have at least stable disease after completion of first-line therapy comprising pemetrexed disodium with cisplatin or carboplatin.

Secondary

- To determine the overall survival of patients treated with this regimen versus observation.

- To evaluate the frequency of responses in patients treated with this regimen.

- To assess the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to first-line chemotherapy regimen (cisplatin/pemetrexed disodium vs carboplatin/pemetrexed disodium) and histologic subtype (epithelioid vs other).

- Arm I: 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.

- Arm II: Patients undergo observation until disease progression. After completion of study therapy, patients are followed up every 6 months for 3 years.

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Conditions

Malignant Mesothelioma

Intervention

pemetrexed disodium, clinical observation

Location

Wayne Memorial Hospital, Incorporated
Goldsboro
North Carolina
United States
27534

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:17-0400

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Medical and Biotech [MESH] Definitions

A peritoneal mesothelioma affecting mainly young females and producing cysts of variable size and number lined by a single layer of benign mesothelial cells. The disease follows a benign course and is compatible with a normal life expectancy, requiring occasionally partial excision or decompression for relief of pain or other symptoms. Malignant potential is exceptional. (From Holland et al., Cancer Medicine, 3d ed, p1345)

A rare neoplasm, usually benign, derived from mesenchymal fibroblasts located in the submesothelial lining of the PLEURA. It spite of its various synonyms, it has no features of mesothelial cells and is not related to malignant MESOTHELIOMA or asbestos exposure.

The act of regarding attentively and studying facts and occurrences, gathering data through analyzing, measuring, and drawing conclusions, with the purpose of applying the observed information to theoretical assumptions. Observation as a scientific method in the acquisition of knowledge began in classical antiquity; in modern science and medicine its greatest application is facilitated by modern technology. Observation is one of the components of the research process.

A guanine-derived ANTINEOPLASTIC AGENT that functions as a NUCLEIC ACID SYNTHESIS INHIBITOR through its binding to, and inhibition of, THYMIDYLATE SYNTHASE.

A vocabulary database of universal identifiers for laboratory and clinical test results. Its purpose is to facilitate the exchange and pooling of results for clinical care, outcomes management, and research. It is produced by the Regenstrief Institute. (LOINC and RELMA [Internet]. Indianapolis: The Regenstrief Institute; c1995-2001 [cited 2002 Apr 2]. Available from http://www.regenstrief.org/loinc)

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