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

NCT00791336 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 200802788
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

NSCLC; chemotherapy; radiation therapy; nelfinavir; NFV

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response

  30 days

Secondary Outcomes (2)

• Characterization of Overall and Disease-free Survival

  long-term

• Safety and Tolerability of the Combined Treatment Regimen

  7 weeks

Study Arms (1)

Nelfinavir

EXPERIMENTAL

Drug: Nelfinavir

Interventions

Nelfinavir DRUG

1250 mg twice daily starting for approximately 6.5 weeks.

Also known as: Viracept

Nelfinavir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

The University of Iowa Department of Radiation Oncology

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nelfinavir

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

There was only one treated participant. Conclusions cannot be drawn from these data due to limited sampling size.

Results Point of Contact

• Title: John M. Buatti, M.D., Chair, Department of Radiation Oncology
• Organization: The University of Iowa

john-buatti@uiowa.edu

319-356-2699

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 14, 2008
• Study Start: August 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: July 28, 2017
• Results First Posted: July 28, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)