|Phase III||Treatment||Completed||Over 18||Other||EORTC-08983|
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.
Further Study Information
- 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.
- Histologically confirmed malignant pleural mesothelioma
- No CNS metastases
- Over 18
- ZUBROD, ECOG, WHO 0-2
- Not specified
- 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
- 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)
- Creatinine less than 1.69 mg/dL
- Creatinine clearance at least 65 mL/min
- Not specified
- Not specified
- 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:
- No concurrent immunotherapy before first disease progression
- 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)
- No concurrent hormonal therapy except corticosteroids before first disease progression
- 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
- Prior surgery allowed if followed by disease progression
- At least 1 month since prior investigational drugs
Trial Lead Organizations/Sponsors
European Organization for Research and Treatment of Cancer
|Jan P. Van Meerbeeck||Study Chair|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00004920
Information obtained from ClinicalTrials.gov on January 07, 2013
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