Status:
COMPLETED
Pemetrexed Disodium and Cisplatin Followed by Surgery With or Without Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma
Lead Sponsor:
Swiss Cancer Institute
Conditions:
Malignant Mesothelioma
Eligibility:
All Genders
18-69 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividin...
Detailed Description
OBJECTIVES: Primary * Evaluate the short-term outcomes and feasibility of neoadjuvant therapy with pemetrexed disodium and cisplatin followed by extrapleural pneumonectomy in patients with malignant...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed malignant pleural mesothelioma
- T1-3, N0-2, M0 disease according to International Mesothelioma Interest Group staging system
- No obvious invasion of mediastinal structures by CT scan (e.g., heart, aorta, spine, esophagus)
- No obvious widespread chest wall invasion
- Resectable chest wall lesions allowed
- PATIENT CHARACTERISTICS:
- WHO performance score 0-1
- Fit for neoadjuvant therapy, surgery, and postoperative radiotherapy
- Creatinine clearance \> 60 mL/min
- Hemoglobin ≥ 10.0 g/dL
- WBC ≥ 3,500/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 1.5 times ULN
- Alkaline phosphatase ≤ 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for up to 12 months after completion of study treatment
- FEV\_1 ≥ 40% of predicted based on spirometry and lung perfusion scan, if necessary
- No serious underlying medical condition that would preclude study requirements (e.g., active autoimmune disease or uncontrolled diabetes)
- No known hypersensitivity against pemetrexed disodium, cisplatin, or other platinum-containing substances or any other components used for the preparation of the drugs
- No restricted power of hearing (especially in the upper frequency range)
- No acute infections
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy
- No treatment on another clinical trial within the past 30 days
- No prior pleurectomy or lung resection
- No prior radiotherapy of the lower neck, thorax, or upper abdomen
- No aspirin, cyclooxygenase-2 inhibitors, or nonsteroidal anti-inflammatory agents for 5 days prior to, during, and for 2 days after pemetrexed disodium administration
- No other concurrent experimental drugs or anticancer therapy
- No concurrent drugs that would contraindicate study drugs
- No concurrent vaccination against yellow fever
Exclusion
Key Trial Info
Start Date :
November 14 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2018
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00334594
Start Date
November 14 2005
End Date
January 23 2018
Last Update
May 15 2019
Active Locations (13)
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1
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Germany, D-79106
2
Kantonsspital Aarau
Aarau, Switzerland, CH-5001
3
Kantonsspital Baden
Baden, Switzerland, CH-5404
4
Universitaetsspital-Basel
Basel, Switzerland, CH-4031