Nelfinavir, Radiation Therapy, Cisplatin, and Etoposide in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Nelfinavir may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Nelfinavir may make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving nelfinavir together with radiation therapy, cisplatin, and etoposide may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of nelfinavir when given together with radiation therapy, cisplatin, and etoposide and to see how well they work in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Etoposide; Etoposide phosphate; Nelfinavir

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed non-small cell lung cancer

• Locally advanced (stage III) disease

• Unresectable disease

• Candidate for concurrent definitive chemotherapy and thoracic radiotherapy, as determined by the treating physician

• No malignant pleural effusion

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Absolute neutrophil count > 1,500/mm³

• Platelet count > 100,000/mm³

• Bilirubin ≤ 1.5 mg/dL

• AST or ALT ≤ 2 times upper limit of normal (ULN)

• Creatinine ≤ 1.5 times ULN

• FEV_1 > 600 cc

• Not pregnant or nursing

• Negative pregnancy test

• No weight loss > 10% within the past 6 months

• No known HIV disease

PRIOR CONCURRENT THERAPY:

• No prior thoracic radiotherapy

• No prior HIV protease inhibitors

• More than 5 years since prior chemotherapy

• At least 3 weeks since prior exploratory thoracotomy

• No concurrent medications that would preclude nelfinavir administration, including any of the following:

• Amiodarone

• Quinidine

• Rifampin

• Dihydroergotamine

• Ergonovine

• Ergotamine

• Methylergonovine

• Hypericum perforatum (St. John's wort)

• Lovastatin

• Simvastatin

• Pimozide

• Midazolam

• Triazolam