Overview

This trial is active, not recruiting.

Condition malignant mesothelioma
Treatments cisplatin, methotrexate, vinorelbine ditartrate, adjuvant therapy, conventional surgery, neoadjuvant therapy, 3-dimensional conformal radiation therapy, intensity-modulated radiation therapy
Phase phase 2
Sponsor Case Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date August 2002
Trial size 36 participants
Trial identifier NCT00354393, CASE-CCF-0755, CASE-CCF-IRB-5179, CDR0000486304

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Response to chemotherapy
time frame:

Secondary Outcomes

Measure
Tolerability and toxicity
time frame:
Relapse free and overall survival
time frame:
Operability and surgical success
time frame:
Quality of life
time frame:

Eligibility Criteria

Male or female participants up to 75 years old.

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

Additional Information

Official title Aggressive Multi-Modality Management of Malignant Pleural Mesothelioma
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).