Pemetrexed Disodium and Cisplatin Followed by Surgery With or Without Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma

• Status: Completed
• Trial end date: 2018-01-23
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium 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. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium together with cisplatin followed by surgery with or without radiation therapy works in treating patients with malignant pleural mesothelioma.

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

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Treatments: Cisplatin; Pemetrexed

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed malignant pleural mesothelioma

• T1-3, N0-2, M0 disease according to International Mesothelioma Interest Group staging system

• No obvious invasion of mediastinal structures by CT scan (e.g., heart, aorta, spine, esophagus)

• No obvious widespread chest wall invasion

• Resectable chest wall lesions allowed

PATIENT CHARACTERISTICS:

• WHO performance score 0-1

• Fit for neoadjuvant therapy, surgery, and postoperative radiotherapy

• Creatinine clearance > 60 mL/min

• Hemoglobin ≥ 10.0 g/dL

• WBC ≥ 3,500/mm³

• Absolute neutrophil count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• AST and ALT ≤ 1.5 times ULN

• Alkaline phosphatase ≤ 1.5 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for up to 12 months after completion of study treatment

• FEV_1 ≥ 40% of predicted based on spirometry and lung perfusion scan, if necessary

• No serious underlying medical condition that would preclude study requirements (e.g., active autoimmune disease or uncontrolled diabetes)

• No known hypersensitivity against pemetrexed disodium, cisplatin, or other platinum-containing substances or any other components used for the preparation of the drugs

• No restricted power of hearing (especially in the upper frequency range)

• No acute infections

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy

• No treatment on another clinical trial within the past 30 days

• No prior pleurectomy or lung resection

• No prior radiotherapy of the lower neck, thorax, or upper abdomen

• No aspirin, cyclooxygenase-2 inhibitors, or nonsteroidal anti-inflammatory agents for 5 days prior to, during, and for 2 days after pemetrexed disodium administration

• No other concurrent experimental drugs or anticancer therapy

• No concurrent drugs that would contraindicate study drugs

• No concurrent vaccination against yellow fever