Aggressive Multi-Modality Management of Malignant Pleural Mesothelioma
N/A
75 Years
Both
Malignant Mesothelioma
Trial Information
Aggressive Multi-Modality Management of Malignant Pleural Mesothelioma
OBJECTIVES:
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response to chemotherapy
Safety Issue:
No
Principal Investigator
David J. Adelstein, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000486304
NCT ID:
NCT00354393
Start Date:
August 2002
Completion Date:
Related Keywords:
- Malignant Mesothelioma
- localized malignant mesothelioma
- sarcomatous mesothelioma
- advanced malignant mesothelioma
- epithelial mesothelioma
- Mesothelioma
Name | Location |
|---|---|
| Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
