Status:
COMPLETED
Combination Chemotherapy With or Without Surgery & Chemoradiotherapy in Patients With Malignant Pleural Mesothelioma
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Malignant Mesothelioma
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as methotrexate, vinorelbine, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from ...
Detailed Description
OBJECTIVES: Primary * Assess the response to induction combination chemotherapy comprising methotrexate, vinorelbine ditartrate, and cisplatin in patients with previously untreated malignant pleural...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed malignant pleural mesothelioma
- Amenable to aggressive surgical resection, if deemed resectable
- Patients with potentially resectable disease must have undergone mediastinoscopy to establish surgical stage
- Resectable disease is defined as any of the following:
- Epithelioid, mixed histology, or histology not otherwise specified with clinical stage I-III (T1-3, N0-2, M0) disease
- Sarcomatoid histology with clinical stage I-III (T1-3, N0) disease
- Intraperitoneal extension, contralateral thoracic extension, or distant metastases are eligible, but considered unresectable
- Disease considered unresectable by any medical reason or if surgery was declined
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC ≥ 3,000/mm³
- Platelet count \> 100,000/mm³
- Creatinine ≤ 1.7 mg/dL
- Alkaline phosphatase \< 2 times normal
- AST \< 2 times normal
- Albumin \> 3 g/dL
- Bilirubin \< 2.0 mg/dL
- Patients must be available for and compliant with adequate long-term follow-up
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- Patients with resectable disease must have adequate pulmonary function to undergo surgery and radiotherapy
- No other active malignancies
- PRIOR CONCURRENT THERAPY:
- No prior surgical resection, radiation therapy, chemotherapy, or immunotherapy for this cancer
Exclusion
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00354393
Start Date
August 1 2002
End Date
June 1 2009
Last Update
July 15 2025
Active Locations (1)
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1
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065