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Mesothelioma Related Clinical Trials:
Neoadjuvant Chemotherapy and Extrapleural Pneumonectomy of Malignant Pleural Mesothelioma (MPM) With or Without Hemithoracic Radiotherapy. A Randomized Multicenter Phase II Trial
- General Info - Purpose - Eligibility - Contacts & Locations - Additional Information
Status: Recruiting
Sponsors and Collaborators: Swiss Group for Clinical Cancer Research
Information provided by: National Cancer Institute (NCI)
Government Identifier: NCT00334594
Condition: Malignant Mesothelioma
Intervention: Drug: cisplatin; Drug: pemetrexed disodium; Procedure: adjuvant therapy; Procedure: chemotherapy; Procedure: conventional surgery; Procedure: diagnostic procedure; Procedure: enzyme inhibitor therapy; Procedure: laboratory biomarker analysis; Procedure: neoadjuvant therapy; Procedure: quality-of-life assessment; Procedure: radiation therapy
Purpose:
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 dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium together with cisplatin followed by surgery with or without radiation therapy works in treating patients with malignant pleural mesothelioma.
| Study Type: Â | Interventional |
| Study Design: Â | Treatment, Randomized, Open Label |
| Official Title: Â | Neoadjuvant Chemotherapy and Extrapleural Pneumonectomy of Malignant Pleural Mesothelioma (MPM) With or Without Hemithoracic Radiotherapy. A Randomized Multicenter Phase II Trial |
- Complete macroscopic resection (part 1) [ Designated as safety issue: No ]
- Loco-regional relapse-free survival (part 2) [ Designated as safety issue: No ]
- Response to neoadjuvant therapy (part 1) [ Designated as safety issue: No ]
- Adverse drug reaction to neoadjuvant therapy (part 1) [ Designated as safety issue: Yes ]
- Operability (part 1) [ Designated as safety issue: No ]
- Surgical complications (part 1) [ Designated as safety issue: No ]
- Reasons for non-randomization (part 1) [ Designated as safety issue: No ]
- Relapse-free or progression-free survival (part 1) [ Designated as safety issue: No ]
- Adverse reaction to postoperative radiotherapy (part 2) [ Designated as safety issue: Yes ]
- Late toxicity (part 2) [ Designated as safety issue: Yes ]
- Feasibility of postoperative radiotherapy (part 2) [ Designated as safety issue: No ]
- Relapse-free survival (part 2) [ Designated as safety issue: No ]
- Psychological distress (quality of life) (part 2) [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Estimated Enrollment: Â | 155 |
| Study Start Date: Â | November 2005 |
| Estimated Primary Completion Date: Â | December 2012 (Final data collection date for primary outcome measure) |
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 pleural mesothelioma.
- Evaluate the long-term outcomes and feasibility of postoperative hemithoracic radiotherapy in patients with R0 or R1 resection.
Secondary
- Determine the quality of life of these patients.
- Identify predictive and prognostic markers in these patients.
- Determine relapse-free or progression-free survival and overall survival of these patients.
- Collect tissue and blood from these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, histology (sarcomatous or other vs epithelial or mixed histology), nodal status (N0-1 vs N2), and extent of disease (T1-2 vs T3).
- Part 1 (neoadjuvant therapy and surgery): Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Within 8 weeks after completion of neoadjuvant therapy, patients without progressive disease undergo extrapleural pneumonectomy.
-
Part 2 : Patients achieving R0 or R1 resection proceed to part 2 of study treatment and are randomized to 1 of 2 treatment arms. Patients with R2 resection, disease progression, or symptomatic deterioration after treatment in part 1 are taken off study.
- Arm I (no postoperative radiotherapy): Patients do not undergo radiotherapy. Quality of life is assessed at baseline and at 6, 10, 16, and 22 weeks after randomization.
- Arm II (postoperative radiotherapy): Beginning within 10 weeks after surgery, patients undergo radiotherapy to the hemithoracic region 5 days a week for approximately 5 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and at 4, 8, 14, and 20 weeks after initiation of radiotherapy.
Patients undergo blood and tissue collection at registration and surgery for laboratory and biomarker analysis.
After completion of study treatment, patients are followed periodically for up to 5 years after surgery.
PROJECTED ACCRUAL: A total of 155 patients will be accrued for this study.
Eligibility:
| Ages Eligible for Study: | 18 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
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
Contacts and Locations:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00334594Locations
| Switzerland | |||||
| UniversitaetsSpital Zuerich   | Recruiting | ||||
| Â Â Â Zurich, Switzerland, CH-8091 | |||||
|    Contact: Rolf A. Stahel, MD   41-1-634-2871   rolf.stahel@usz.ch   | |||||
Sponsors and Collaborators
| Swiss Group for Clinical Cancer Research |
Investigators
| Study Chair: Â Â | Rolf A. Stahel, MD Â Â | UniversitaetsSpital Zuerich |
Additional Information:
| Study ID Numbers: Â | CDR0000481153, SWS-SAKK-17/04, EU-20615, EUDRACT-2006-000445-19, LILLY-SAKK-17/04 |
| First Received: Â | June 7, 2006 |
| Last Updated: Â | December 25, 2007 |
| ClinicalTrials.gov Identifier: Â | NCT00334594 |
| Health Authority: Â | Unspecified |
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