Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether receiving cisplatin with raltitrexed is more effective than cisplatin alone for malignant mesothelioma. PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin with or without raltitrexed in treating patients who have malignant mesothelioma of the pleura.

Detailed Description
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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.

Official Title
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Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma

Conditions
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Malignant Mesothelioma

Intervention / Treatment
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* Drug: cisplatin
* Drug: raltitrexed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: raltitrexed|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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localized malignant mesothelioma, advanced malignant mesothelioma, recurrent malignant mesothelioma