Combination Chemotherapy With or Without Surgery & Chemoradiotherapy in Patients With Malignant Pleural Mesothelioma
NCT ID: NCT00354393
Last Updated: 2025-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
9 participants
INTERVENTIONAL
2002-08-31
2009-06-30
Brief Summary
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PURPOSE: This phase II trial is studying how well giving combination chemotherapy with or without surgery and chemoradiotherapy works in treating patients with malignant pleural mesothelioma.
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Detailed Description
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Primary
* Assess the response to induction combination chemotherapy comprising methotrexate, vinorelbine ditartrate, and cisplatin in patients with previously untreated malignant pleural mesothelioma.
Secondary
* Assess the tolerability and toxicity of this regimen in these patients.
* Determine relapse-free and overall survival of patients treated with induction combination chemotherapy with or without surgery and hemithoracic radiation.
* Assess the impact of induction combination chemotherapy on operability and surgical success.
* Evaluate the impact of these treatment regimens on quality of life.
OUTLINE:
* Induction chemotherapy: Patients receive MVP chemotherapy comprising cisplatin IV over 30-60 minutes on day 1 and vinorelbine ditartrate IV over 5-10 minutes and methotrexate IV over 5-30 minutes on days 8, 15, and 22. Treatment repeats every 28 days for 2 courses. Patients with unresectable disease may receive up to 2 additional courses of induction chemotherapy. Patients requiring palliative radiotherapy or who have progressive disease are removed from the study. Patients with resectable disease or sarcomatoid histology and T1-3, N1-2 disease with a complete or partial response to induction chemotherapy proceed to surgery.
* Surgery: Patients with extensive disease undergo palliative debulking pleurectomy and decortication and then are taken off study. All other patients undergo a thoracotomy with an extrapleural pneumonectomy and then proceed to chemoradiotherapy.
* Chemoradiotherapy: Beginning 6-10 weeks after surgery, patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients also receive cisplatin IV over 30-60 minutes on days 1 and 22. Patients with responding disease proceed to adjuvant chemotherapy.
* Adjuvant chemotherapy: Patients receive 2 additional courses of MVP chemotherapy as above.
Quality of life is assessed at baseline, after each course of induction chemotherapy, before surgery, and then every 3 months thereafter.
After completion of study therapy, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Induction Combination Chemotherapy
Induction chemotherapy: Patients get MVP chemo. Treatment repeats every 28 days for 2 courses.
Patients w/ unresectable disease may get up to 2 add'l courses of induction chemo. Patients requiring palliative radiotherapy or have PD are removed from study. Patients w/ resectable disease or sarcomatoid histology \& T1-3, N1-2 disease w/ a CR or PR to induction chemo go to surgery.
Surgery: Patients w/ extensive disease get palliative debulking pleurectomy and decortication \& are taken off study. Other patients undergo a thoracotomy w/ extrapleural pneumonectomy \& proceed to chemoradiotherapy.
Chemoradiotherapy: At 6-10 weeks post-op, patients get 3-dimensional conformal or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients receive cisplatin IV over 30-60 minutes days 1 \& 22. Patients w/ responding disease proceed to adjuvant chemotherapy.
Adjuvant chemotherapy: Patients get 2 more courses of MVP chemotherapy
Cisplatin
Methotrexate
Vinorelbine ditartrate
Adjuvant therapy
Conventional surgery
Neoadjuvant Therapy
3-dimensional conformal radiation therapy
Intensity-modulated radiation therapy
Interventions
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Cisplatin
Methotrexate
Vinorelbine ditartrate
Adjuvant therapy
Conventional surgery
Neoadjuvant Therapy
3-dimensional conformal radiation therapy
Intensity-modulated radiation therapy
Eligibility Criteria
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Inclusion Criteria
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
75 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
The Cleveland Clinic
OTHER
Responsible Party
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Principal Investigators
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David J. Adelstein, MD
Role: STUDY_CHAIR
Case Comprehensive Cancer Center
Locations
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Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CASE-CCF-IRB-5179
Identifier Type: OTHER
Identifier Source: secondary_id
CASE-CCF-IRB-5179
Identifier Type: -
Identifier Source: org_study_id
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