Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma
18 Years
N/A
Both
Malignant Mesothelioma
Trial Information
Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Jan P. Van Meerbeeck, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University Medical Center Rotterdam at Erasmus Medical Center
Authority:
United States: Federal Government
Study ID:
EORTC-08983
NCT ID:
NCT00004920
Start Date:
November 1999
Completion Date:
Related Keywords:
- Malignant Mesothelioma
- localized malignant mesothelioma
- advanced malignant mesothelioma
- recurrent malignant mesothelioma
- Mesothelioma
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