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

• ClinicalTrials.gov Identifier: NCT00791336
• Recruitment Status: Terminated
• First Posted: November 14, 2008
• Results First Posted: July 28, 2017
• Last Update Posted: July 28, 2017
• Sponsor: University of Iowa
• Information provided by (Responsible Party): University of Iowa

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Iowa

The University of Iowa Department of Radiation Oncology

Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

University of Iowa

More Information

• Responsible Party: University of Iowa
• ClinicalTrials.gov Identifier: NCT00791336
• Other Study ID Numbers: 200802788
• First Posted: November 14, 2008
• 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.

• 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:

NSCLC; chemotherapy; radiation therapy; nelfinavir; NFV

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Nelfinavir; HIV Protease Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents