Status:
TERMINATED
Study to Evaluate Using Nelfinavir With Chemoradiation for Non-small Cell Lung Cancer
Lead Sponsor:
University of Iowa
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
This is a phase 2 trial of the HIV protease inhibitor (HPI) Nelfinavir (NFV) in combination with radiotherapy and chemotherapy in patients with locally advanced non-small cell lung cancer (NSCLC) who ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00791336
Start Date
August 1 2008
End Date
March 1 2011
Last Update
July 28 2017
Active Locations (1)
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1
The University of Iowa Department of Radiation Oncology
Iowa City, Iowa, United States, 52242