Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Mesothelioma |
Drug: cisplatin Drug: raltitrexed |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma |
| Enrollment: | 256 |
| Study Start Date: | November 1999 |
| Primary Completion Date: | January 2003 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 26 Study Locations| Study Chair: | Jan P. Van Meerbeeck, MD, PhD | University Medical Center Rotterdam at Erasmus Medical Center |
More Information
Additional Information:
Publications:
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00004920 History of Changes |
| Other Study ID Numbers: | EORTC-08983, EORTC-08983 |
| Study First Received: | March 7, 2000 |
| Last Updated: | July 17, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
localized malignant mesothelioma advanced malignant mesothelioma recurrent malignant mesothelioma |
Additional relevant MeSH terms:
|
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Raltitrexed Cisplatin Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 23, 2013