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

Tracking Information

• First Submitted Date: November 13, 2008
• First Posted Date: November 14, 2008
• Results First Submitted Date: March 9, 2017
• Results First Posted Date: July 28, 2017
• Last Update Posted Date: July 28, 2017
• Study Start Date: August 2008
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 13, 2008): Pathologic Complete Response [ Time Frame: 30 days ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 13, 2008)

• Characterization of Overall and Disease-free Survival [ Time Frame: long-term ]
• Safety and Tolerability of the Combined Treatment Regimen [ Time Frame: 7 weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Evaluate Using Nelfinavir With Chemoradiation for Non-small Cell Lung Cancer
• 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
• 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 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Carcinoma, Non-Small-Cell Lung

Intervention

Drug: Nelfinavir

1250 mg twice daily starting for approximately 6.5 weeks.

Other Name: Viracept

Study Arms

Experimental: Nelfinavir

Intervention: Drug: Nelfinavir

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 9, 2015): 1
• Original Estimated Enrollment (submitted: November 13, 2008): 66
• Actual Study Completion Date: March 2011
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00791336
• Other Study ID Numbers: 200802788
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Terminated due to poor enrollment; lack of data to share.

• Responsible Party: University of Iowa
• Study Sponsor: University of Iowa
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Iowa
• Verification Date: June 2017