Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study to Evaluate Using Nelfinavir With Chemoradiation for Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by University of Iowa, November 2008
Sponsored by: University of Iowa
Information provided by: University of Iowa
ClinicalTrials.gov Identifier: NCT00791336
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Nelfinavir
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Nelfinavir Nelfinavir Mesylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title: A Phase II Trial of the HIV Protease Inhibitor Nelfinavir and Concurrent Radiation and Chemotherapy in Patients With Stage III Non Small Cell Lung Cancer

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Pathologic complete response [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • characterization of overall and disease-free survival [ Time Frame: long-term ] [ Designated as safety issue: No ]
  • Safety and tolerability of the combined treatment regimen [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 66
Study Start Date: August 2008
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Nelfinavir: Experimental Drug: Nelfinavir
1250 mg twice daily starting for approximately 6.5 weeks.

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 are considered candidates for pre-operative treatment. This study is to be conducted according to US and international standards of Good Clinical Practice (FDA Title 21 part 312 and International Conference on Harmonization guidelines), applicable government regulations and Institutional research policies and procedures. The endpoints are to determine safety of NFV with chemoradiation, gather preliminary data for response, and tissue specimens for correlative molecular studies. Unacceptable toxicity is unlikely as prior studies have determined dosing 1250 mg twice a day is relatively safe for HIV patients receiving radiation therapy. NFV will start one week prior to chemo-radiotherapy and continue for the duration of chemoradiation (approximately 6 1/2 weeks). Standard radiotherapy (minimum total dose 5040 cGy) and combined (cisplatin/etoposide) chemotherapy based on SWOG 8805 will be delivered in combination with NFV. The thoracic surgery attending physician will determine the feasibility of resection. If the patient has resectable disease, the attending thoracic surgeon will perform the thoracotomy and anatomical resection. If the patient has unresectable disease, subject will be followed for 30 days post NFV administration. After the initial 30 days post-NFV, subjects will be followed for long-term outcomes (disease response and overall survival). Adjuvant therapy may be continued off-study at the discretion of managing oncology personnel. Tumors obtained at the time of surgical resection will be assessed for pathological response. Tumor tissue taken pre-treatment will be assessed for markers that may predict response such as Akt, VEGF, and EGFR.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791336

Contacts
Contact: Jane M. Hershberger, RN, BSN (319) 384-7912 jane-hershberger@uiowa.edu
Contact: Kellie L. Bodeker, CCRC, BS (319) 384-9425 kellie-bodeker@uiowa.edu

Locations
United States, Iowa
The University of Iowa Department of Radiation Oncology Recruiting
Iowa City, Iowa, United States, 52242
Principal Investigator: Anjali K. Gupta, MD            
Sponsors and Collaborators
University of Iowa
  More Information

Responsible Party: Department of Radiation Oncology ( Anjali K. Gupta, M.D. )
Study ID Numbers: 200802788
Study First Received: November 13, 2008
Last Updated: November 13, 2008
ClinicalTrials.gov Identifier: NCT00791336  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
NSCLC
chemotherapy
radiation therapy
nelfinavir
NFV

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
HIV Infections
Lung Diseases
Acquired Immunodeficiency Syndrome
Nelfinavir
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Anti-Infective Agents
HIV Protease Inhibitors
Neoplasms by Histologic Type
Anti-HIV Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Neoplasms
Neoplasms by Site
Anti-Retroviral Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009