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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00004254
First received: January 28, 2000
Last updated: July 17, 2012
Last verified: July 2012
  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 2

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

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 25
Study Start Date: November 1999
Primary Completion Date: June 2001 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Italy
Ospedale Bellaria
Bologna, Italy, I-40139
Istituto Nazionale per la Ricerca sul Cancro
Genoa, Italy, 16132
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, Italy, 80131
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 Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Giuseppe Giaccone, MD, PhD Free University Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00004254     History of Changes
Other Study ID Numbers: EORTC-08992, EORTC-08992
Study First Received: January 28, 2000
Last Updated: July 17, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
localized malignant mesothelioma
advanced malignant mesothelioma
recurrent malignant mesothelioma

Additional relevant MeSH terms:
Lung Neoplasms
Mesothelioma
Neoplasms, Mesothelial
Adenoma
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Raltitrexed
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014