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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Methotrexate; Vinblastine; Vinorelbine

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