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Combination Chemotherapy With or Without Surgery and Chemoradiotherapy in Treating Patients With Malignant Pleural Mesothelioma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: July 19, 2006
Last updated: February 6, 2009
Last verified: October 2007

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 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. Cisplatin may also make tumor cells more sensitive to radiation therapy. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery.

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.

Condition Intervention Phase
Malignant Mesothelioma
Drug: cisplatin
Drug: methotrexate
Drug: vinorelbine ditartrate
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: 3-dimensional conformal radiation therapy
Radiation: intensity-modulated radiation therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Aggressive Multi-Modality Management of Malignant Pleural Mesothelioma

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response to chemotherapy

Secondary Outcome Measures:
  • Tolerability and toxicity
  • Relapse free and overall survival
  • Operability and surgical success
  • Quality of life

Estimated Enrollment: 36
Study Start Date: August 2002
Detailed Description:



  • Assess the response to induction combination chemotherapy comprising methotrexate, vinorelbine ditartrate, and cisplatin in patients with previously untreated malignant pleural mesothelioma.


  • 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.


  • 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.


Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • No prior surgical resection, radiation therapy, chemotherapy, or immunotherapy for this cancer
  Contacts and Locations
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Please refer to this study by its identifier: NCT00354393

United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: David J. Adelstein, MD Case Comprehensive Cancer Center
  More Information Identifier: NCT00354393     History of Changes
Other Study ID Numbers: CDR0000486304
Study First Received: July 19, 2006
Last Updated: February 6, 2009

Keywords provided by National Cancer Institute (NCI):
localized malignant mesothelioma
sarcomatous mesothelioma
advanced malignant mesothelioma
epithelial mesothelioma

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors processed this record on April 25, 2017