Phase III Randomized Study of Cisplatin With or Without Raltitrexed in Patients With Malignant Pleural Mesothelioma

Summary Last Modified 03/2000)

Patient Abstract
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.

Eligibility:

  • At least 19 years old
  • No CNS metastases
  • No previous chemotherapy
  • At least 4 weeks since radiation therapy to the tumor

Treatment: Patients will be randomly assigned to one of two groups. Patients in group one will receive an infusion of raltitrexed followed by an infusion of cisplatin on day 1. Patients in group two will receive an infusion of cisplatin on day 1. Treatment may continue every 3 weeks for as long as benefit is shown. Quality of life will be assessed periodically. Patients will be evaluated every 6 weeks.

This abstract is intended to give a brief overview of this clinical trial. To help determine whether the trial is appropriate for an individual, selected major eligibility criteria are listed above. To obtain more details related to trial eligibility and the treatment plan, please see the Health Professional abstract of this clinical trial. For more information about clinical trials, please visit the NCI cancerTrials website at http://cancertrials.nci.nih.gov.

Protocol IDs: EORTC-08983
Participating Organizations/Investigators
Jan Van Meerbeeck, Chair, Ph: 31 10 4634855
EORTC Lung Cancer Group

Location and Contact Information

Belgium
Algemeen Ziekenhuis Middelheim, Antwerp, 2020, Belgium; Recruiting
Danielle I.T. Galdermans 03--280-3154

Denmark
Rigshospitalet, Copenhagen, 2100, Denmark; Recruiting
Jens Benn Sorensen 3545-4372

France
Assistance Publique Hopitaux de Marseille (Ste Marguerite Salvator Centre Cantini), Marseille, 13274, France; Recruiting
Jean-Pierre Kleisbauer 91-74-47-36

Hopital Charles Nicolle, Rouen, 76031, France; Recruiting
L. Thiberville 33-2-32-88-82-47

Hopital de la Conception, Marseille, 13385, France; Recruiting
Philippe Astoul 33 49 148 9515

Germany
Haematologisch-Onkologische Praxis Altona, Hamburg, D-22765, Germany; Recruiting
Ulrich R. Kleeberg 0049-40-38021232

Thoraxklinik Rohrbach, Heidelberg, D-69126, Germany; Recruiting
Christian Manegold 0049-6221-3961

Italy
Istituto Nazionale per la Ricerca sul Cancro, Genoa (Genova), 16132, Italy; Recruiting
Andrea Ardizzoni 010-5600-668

Istituto Nazionale per lo Studio e la Cura dei Tumori, Naples (Napoli), 80131, Italy; Recruiting
Cesare Gridelli 39-81-590 32 69

Ospedale Bellaria, Bologna, I-40139, Italy; Recruiting
Lucio Crino 39-75-5783438

Ospedale St. Santa Chiara, Pisa, 56100, Italy; Recruiting
Editta Baldini 39-50-992540

Netherlands
Academisch Ziekenhuis der Vrije Universiteit, Amsterdam, 1117 MB, Netherlands; Recruiting
Giuseppe Giaccone 31-20-444-43-0036

Academisch Ziekenhuis Groningen, Groningen, 9713 EZ, Netherlands; Recruiting
Hendricus Groen 31-50-3612357

Academisch Ziekenhuis Utrecht, Utrecht, 3508 GA, Netherlands; Recruiting
Noel Jean Joseph Schlosser 30--250-9111

Catharina Ziekenhuis, Eindhoven, 5602 ZA, Netherlands; Recruiting
R. Schipper 31 40 2399111

Groot Ziekengasthuis 's-Hertogenbosch, 's-Hertogenbosch, 5211 NL, Netherlands; Recruiting
Boone Biesma 073-616-2441

Leiden University Medical Center, Leiden, 2300 ZA, Netherlands; Recruiting
L. Willems 071-5263742

University Hospital - Rotterdam Dijkzigt, Rotterdam, 3000 CA, Netherlands; Recruiting
Jan Van Meerbeeck 31 10 4634855

Ziekenhuis Lievensberg, Bergen-op-Zoom, 4624 VT, Netherlands; Recruiting
Boen-Hauw Liem +31-164-278000

Ziekenhuis Walcheren, Vlissingen, Netherlands; Recruiting
G.J.M. Creemers 040-2399111

Norway
Haukeland Hospital - University of Bergen, Bergen, N-5021, Norway; Recruiting
Sverre Sorenson 46-21-173253

Peru
Instituto de Enfermedades Neoplasicas, Lima, 34, Peru; Recruiting
Henry Gomez 511 14 2711143

Poland
Maritime Hospital, Gdynia, PL-81--519, Poland; Recruiting
Hanna Karnicka-Mlodkowska 48-58-220001, ext. 102,105

Medical University of Gdansk, Gdansk, 80-211, Poland; Recruiting
Jacek Jassem 48-58-3492270

Oncology Centre Institute, Warsaw, 02 781, Poland; Recruiting
Maciej Krzakowski 48-22-644-50-24

Sweden
Sahlgrenska University Hospital, Gothenburg (Goteborg), S-413 45, Sweden; Recruiting
Bengt Bergman +46-31-603354

Switzerland
Inselspital, Bern, Bern, CH-3010, Switzerland; Recruiting
D.C. Betticher 011-41-31-632-84-42

Kantonsspital - Saint Gallen, Saint Gallen, CH-9007, Switzerland; Recruiting
Thomas Von Briel 00411-387-37-80

University Hospital, Basel, CH-4031, Switzerland; Recruiting
Miklos Pless 4161 265 53 07

England, United Kingdom
Christie Hospital N.H.S. Trust, Manchester, England, M20 4BX, United Kingdom; Recruiting
Malcolm Ranson 061-446-3000

Derriford Hospital, Plymouth, England, PL6 8DH, United Kingdom; Recruiting
Matthew Collinson 44 1752 777111

Nottingham City Hospital NHS Trust, Nottingham, England, NG5 1PB, United Kingdom; Recruiting
Penella Woll 115 962 79 27

Saint Bartholomew's Hospital, London, England, EC1A 7BE, United Kingdom; Recruiting
Robin Rudd +44-0-207377-7000, ext. 2619

Weston Park Hospital, Sheffield, England, S1O 2SJ, United Kingdom; Recruiting
Matthew Hatton 0114 226 5000

** POSTED AUGUST 30, 2000 **