Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma
cisplatin
+ raltitrexed
Adenoma+11
+ Lung Diseases
+ Lung Neoplasms
Treatment Study
Summary
Study start date: November 1, 1999
Actual date on which the first participant was enrolled.OBJECTIVES: Compare overall survival in patients with malignant pleural mesothelioma treated with raltitrexed with or without cisplatin. Assess toxicity, progression free survival, and quality of life with these treatment regimens in these patients. Evaluate objective response and duration of response to these treatment regimens in patients with measurable disease. OUTLINE: This is a randomized, open, multicenter study. Patients are stratified according to performance status (0 vs 1-2) and WBC count (less than 8,300/mm3 vs 8,300/mm3 or more). Patients are randomized to one of two treatment arms. Arm I: Patients receive cisplatin IV over 1-2 hours on day 1. Arm II: Patients receive raltitrexed IV over 15 minutes followed by cisplatin IV over 1-2 hours on day 1. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before study, prior to each course, after the last course, and then every 6 weeks for 1 year. Patients are followed every 6 weeks until death. PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study over 24 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.256 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignant pleural mesothelioma No CNS metastases PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ZUBROD, ECOG, WHO 0-2 Life expectancy: Not specified Hematopoietic: Hemoglobin at least 10.0 g/dL WBC at least 4,000/mm^3 Absolute neutrophil count at least 2,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin less than 1.46 mg/dL Albumin at least 3.0 g/dL ALAT/ASAT 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 Cardiovascular: Not specified Pulmonary: Not specified Other: No other prior or concurrent malignancies within past 5 years except adequately treated carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin No prior malignant melanoma, hypernephroma or breast carcinoma Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No uncontrolled infections No psychological, familial, sociological, or geographical condition that precludes study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy before first disease progression Chemotherapy: No prior systemic or intracavitary cytotoxic chemotherapy No other prior or concurrent chemotherapy before first disease progression No prior or concurrent pleurodesis with cytotoxic drugs (e.g., bleomycin) Endocrine therapy: No concurrent hormonal therapy except corticosteroids before first disease progression Radiotherapy: At least 4 weeks since prior radiotherapy to target lesion and progression observed Concurrent palliative radiotherapy to painful lesions allowed only if target lesion outside of irradiated field Surgery: Prior surgery allowed if followed by disease progression Other: At least 1 month since prior investigational drugs
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 26 locations
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, CanadaCancer Care Ontario-London Regional Cancer Centre
London, CanadaTrillium Health Centre
Mississauga, Canada