Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed Over 18 EORTC-08992 NCT00004254

Objectives

I. Determine the therapeutic activity and toxicities of raltitrexed in 
patients with inoperable malignant mesothelioma.

II. Determine the objective response rate and duration of response in patients 
treated with this regimen.

Entry Criteria

Disease Characteristics:

Histologically proven inoperable malignant mesothelioma 
 All tumor stages eligible

At least 1 target lesion with measurable disease in at least 1 dimension (20
cm or more with conventional techniques OR 10 cm or more with spiral CT scans)
 Outside irradiated field

Prior surgery allowed if evidence of disease progression thereafter

No signs or symptoms of CNS metastases

Prior/Concurrent Therapy:

Biologic therapy:
 No concurrent anticancer immunotherapy before first disease progression

Chemotherapy:
 No prior systemic or intracavitary cytotoxic drugs
 No concurrent intrapleural or other systemic cytotoxic drugs 

Endocrine therapy:
 No concurrent anticancer hormonal agents (except corticosteroids) before
  first disease progression

Radiotherapy:
 See Disease Characteristics
 Concurrent palliative radiotherapy allowed for painful lesions, needle
  tracts, or surgical scars or prevention of metastases along biopsy tracks
 At least 4 weeks since prior radiotherapy  
 No prior radiotherapy to sole indicator lesion unless lesion is clearly
  progressive 

Surgery:
 See Disease Characteristics
 Prior pleurodesis allowed except with cytotoxic drugs (e.g., bleomycin)
 Concurrent pleurodesis with noncytotoxic drugs allowed

Other: 
 At least 1 month since other prior investigational agent
 No other concurrent anticancer agents before first disease progression

Patient Characteristics:

Age:
 Over 18 

Performance status:
 ZUBROD/ECOG/WHO 0-2 (after palliative measures such as pleural drainage)

Life expectancy:
 Not specified

Hematopoietic:
 Hemoglobin at least 10.0 g/dL
 WBC at least 4,000/mm3
 Absolute neutrophil count at least 2,000/mm3
 Platelet count at least 100,000/mm3

Hepatic:
 Bilirubin less than 1.46 mg/dL
 Albumin at least 3.0 g/dL
 ALT and AST less than 2.5 times upper limit of normal (ULN) (less than 5
  times ULN if liver involvement)

Renal:
 Creatinine less than 1.69 mg/dL
 Creatinine clearance at least 65 mL/min

Other:
 No other malignancies (including melanoma, hypernephroma, or breast
  carcinoma) within the past 5 years except basal cell or squamous cell skin
  cancer or carcinoma in situ of the cervix  
 Not pregnant or nursing
 Fertile patients must use effective contraception
 No uncontrolled infection
 No psychologic, familial, sociologic, or geographic condition that could
  interfere with compliance

Expected Enrollment

A total of 24 patients will be accrued for this study. 

Outline

This is a multicenter study.

Within 2 weeks of staging procedures, patients receive raltitrexed IV over 15 
minutes on day 1.  Treatment repeats every 3 weeks for a maximum of 8 courses 
in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 weeks until disease progression and then every 8 
weeks thereafter for survival.  

Baas P, Ardizzoni A, Grossi F, et al.: The activity of raltitrexed (Tomudex) in malignant pleural mesothelioma: an EORTC phase II study (08992). Eur J Cancer 39 (3): 353-7, 2003.[PUBMED Abstract]

Francart J, Legrand C, Sylvester R, et al.: 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 24 (19): 3007-12, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Giuseppe Giaccone, MD, PhD, Protocol chair(Contact information may not be current)		Ph: 31-20-444-4321 Email: g.giaccone@vumc.nl

Registry Information
Official Title		Phase II Study on Tomusex in Malignant Mesothelioma
Trial Start Date		1999-11-03
Registered in ClinicalTrials.gov		NCT00004254
Date Submitted to PDQ		2000-01-03
Information Last Verified		2007-02-06