Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether receiving cisplatin with raltitrexed is more effective than cisplatin alone for malignant mesothelioma. PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin with or without raltitrexed in treating patients who have malignant mesothelioma of the pleura.

Timeline

Start

1999-11

Primary completion

2003-01

Completion

—

Outcome

Met primary endpoint

paper A combination of raltitrexed and cisplatin improves overall survival compared with cisplatin alone. PMID 16192580 ↗

paper 8.8 (95% CI, 7.8 to 10.8) v 11.4 months (95% CI, 10.1 to 15), respectively, and 40% v 46%, respectively (P = .048). PMID 16192580 ↗

Publications

• Background Francart J, Legrand C, Sylvester R, Van Glabbeke M, van Meerbeeck JP, Robert A. Progression-free survival rate as primary end point for phase II cancer clinical trials: application to mesothelioma--The EORTC Lung Cancer Group. J Clin Oncol. 2006 Jul 1;24(19):3007-12. doi: 10.1200/JCO.2005.05.1359.
• Results Bottomley A, Coens C, Efficace F, Gaafar R, Manegold C, Burgers S, Vincent M, Legrand C, van Meerbeeck JP; EORTC-NCIC. Symptoms and patient-reported well-being: do they predict survival in malignant pleural mesothelioma? A prognostic factor analysis of EORTC-NCIC 08983: randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma. J Clin Oncol. 2007 Dec 20;25(36):5770-6. doi: 10.1200/JCO.2007.12.5294.
• Results Bottomley A, Gaafar R, Manegold C, Burgers S, Coens C, Legrand C, Vincent M, Giaccone G, Van Meerbeeck J; EORTC Lung-Cancer Group; National Cancer Institute, Canada. Short-term treatment-related symptoms and quality of life: results from an international randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma: an EORTC Lung-Cancer Group and National Cancer Institute, Canada, Intergroup Study. J Clin Oncol. 2006 Mar 20;24(9):1435-42. doi: 10.1200/JCO.2005.03.3027. Epub 2006 Jan 30.
• Results van Meerbeeck JP, Gaafar R, Manegold C, Van Klaveren RJ, Van Marck EA, Vincent M, Legrand C, Bottomley A, Debruyne C, Giaccone G; European Organisation for Research and Treatment of Cancer Lung Cancer Group; National Cancer Institute of Canada. Randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma: an intergroup study of the European Organisation for Research and Treatment of Cancer Lung Cancer Group and the National Cancer Institute of Canada. J Clin Oncol. 2005 Oct 1;23(28):6881-9. doi: 10.1200/JCO.20005.14.589.
• Results Van Meerbeeck JP, Manegold C, Gaafar R, et al.: A randomized phase III study of cisplatin with or without raltitrexed in patients (pts) with malignant pleural mesothelioma (MPM): an intergroup study of the EORTC Lung Cancer Group and NCIC. [Abstract] J Clin Oncol 22 (Suppl 14): A-7021, 622s, 2004.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	80 mg/m2	Intravenous
Subject	Raltitrexed	Small molecule	3 mg/m2	Intravenous

Indications