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Aggressive Multi-Modality Management of Malignant Pleural Mesothelioma

Phase 2
75 Years
Open (Enrolling)
Malignant Mesothelioma

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Trial Information

Aggressive Multi-Modality Management of Malignant Pleural Mesothelioma



- 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

- 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

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.

Inclusion Criteria


- 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)

- Intraperitoneal extension, contralateral thoracic extension, or distant
metastases are eligible, but considered unresectable

- Disease considered unresectable by any medical reason or if surgery was


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response to chemotherapy

Safety Issue:


Principal Investigator

David J. Adelstein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 2002

Completion Date:

Related Keywords:

  • Malignant Mesothelioma
  • localized malignant mesothelioma
  • sarcomatous mesothelioma
  • advanced malignant mesothelioma
  • epithelial mesothelioma
  • Mesothelioma



Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065