Brief Title
Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed
Official Title
Phase II Study on Tomusex in Malignant Mesothelioma
Brief Summary
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.
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.
Study Phase
Phase 2
Study Type
Interventional
Condition
Malignant Mesothelioma
Intervention
raltitrexed
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
25
Start Date
November 1999
Primary Completion Date
June 2001
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Giuseppe Giaccone, MD, PhD, ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT00004254
Organization ID
EORTC-08992
Secondary IDs
EORTC-08992
Responsible Party
Sponsor
Study Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor
Giuseppe Giaccone, MD, PhD, Study Chair, Free University Medical Center
Verification Date
July 2012