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

This study is ongoing, but not recruiting participants.

Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004254
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of raltitrexed in treating patients who have malignant mesothelioma that cannot be surgically removed.


Condition Intervention Phase
Malignant Mesothelioma
Drug: raltitrexed
Phase II

MedlinePlus related topics:   Cancer    Mesothelioma   

Drug Information available for:   ICI D1694   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Study on Tomusex in Malignant Mesothelioma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   November 1999

Detailed Description:

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.

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.

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

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004254

Locations
Italy
Istituto Nazionale per la Ricerca sul Cancro    
      Genoa, Italy, 16132
Istituto Nazionale per lo Studio e la Cura dei Tumori    
      Naples, Italy, 80131
Ospedale Bellaria    
      Bologna, Italy, I-40139
Universita Degli Studi di Udine    
      Udine, Italy, 33100
Netherlands
Antoni van Leeuwenhoekhuis    
      Amsterdam, Netherlands, 1066 CX
Vrije Universiteit Medisch Centrum    
      Amsterdam, Netherlands, 1117 MB

Sponsors and Collaborators
European Organization for Research and Treatment of Cancer

Investigators
Study Chair:     Giuseppe Giaccone, MD, PhD     Free University Medical Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Other Publications:

Study ID Numbers:   CDR0000067501, EORTC-08992
First Received:   January 28, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00004254
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized malignant mesothelioma  
advanced malignant mesothelioma  
recurrent malignant mesothelioma  

Study placed in the following topic categories:
Folic Acid
Mesothelioma
Raltitrexed
Adenoma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Mesothelial
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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