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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00791336
Recruitment Status : Terminated (Poor enrollment.)
First Posted : November 14, 2008
Results First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Information provided by (Responsible Party):
University of Iowa

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Nelfinavir Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Nelfinavir Drug: Nelfinavir
1250 mg twice daily starting for approximately 6.5 weeks.
Other Name: Viracept

Primary Outcome Measures :
  1. Pathologic Complete Response [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Characterization of Overall and Disease-free Survival [ Time Frame: long-term ]
  2. Safety and Tolerability of the Combined Treatment Regimen [ Time Frame: 7 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00791336

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United States, Iowa
The University of Iowa Department of Radiation Oncology
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
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Responsible Party: University of Iowa Identifier: NCT00791336    
Other Study ID Numbers: 200802788
First Posted: November 14, 2008    Key Record Dates
Results First Posted: July 28, 2017
Last Update Posted: July 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Terminated due to poor enrollment; lack of data to share.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Iowa:
radiation therapy
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents