Study to Evaluate Using Nelfinavir With Chemoradiation for Non-small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study combines nelfinavir (NFV) with radiation therapy and chemotherapy as a treatment for non-small cell lung cancer (NSCLC) who are considered candidates for pre-operative treatment.

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

Details

• Lead Sponsor: University of Iowa
• Treatments: HIV Protease Inhibitors; Nelfinavir

Criteria

Inclusion Criteria:

• Histological diagnosis of non-small cell lung cancer that is Stage III (T1-3, pN2, M0) NSCLC in whom neoadjuvant therapy is recommended.

• Must have had a mediastinoscopy to determine nodal status and potential resectability

• Must have enough tissue from the biopsy for tissue marker determination for correlative studies

• Negative metastatic work up (FDG PET/CT, brain CT or MRI)

• No prior thoracic radiotherapy will be permitted

• Age 18 years or greater

• ECOG performance status 0-1 (Karnofsky at least 70%)

• Normal organ and marrow function

• No known HIV infection

• Not pregnant

• Ability to understand and the willingness to sign an informed consent document

Exclusion Criteria:

• Patients requiring a pneumonectomy

• Patients who have had chemotherapy or radiation therapy within 4 weeks prior to entering the study, or who have not recovered from adverse events due to agents administered earlier.

• Prior thoracic radiation

• Treatment with any other investigational agents.

• Known metastases

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to NFV

• Patients receiving drugs contraindicated with NFV will be excluded.

• Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study compliance.

• Pregnant or lactating women

• HIV-positive patients on combination antiretroviral therapy