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

This study has been terminated.
(Poor enrollment.)
Sponsor:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00791336
First received: November 13, 2008
Last updated: August 9, 2010
Last verified: August 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791336

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

No publications provided

Responsible Party: Anjali K. Gupta, M.D., Department of Radiation Oncology
ClinicalTrials.gov Identifier: NCT00791336     History of Changes
Other Study ID Numbers: 200802788
Study First Received: November 13, 2008
Last Updated: August 9, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Protease Inhibitors
Nelfinavir
HIV Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014