- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00791336
Study to Evaluate Using Nelfinavir With Chemoradiation for Non-small Cell Lung Cancer
June 29, 2017 updated by: University of Iowa
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / 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
Enrollment (Actual)
1
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- The University of Iowa Department of Radiation Oncology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nelfinavir
|
1250 mg twice daily starting for approximately 6.5 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pathologic Complete Response
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Characterization of Overall and Disease-free Survival
Time Frame: long-term
|
long-term
|
Safety and Tolerability of the Combined Treatment Regimen
Time Frame: 7 weeks
|
7 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
November 13, 2008
First Submitted That Met QC Criteria
November 13, 2008
First Posted (Estimate)
November 14, 2008
Study Record Updates
Last Update Posted (Actual)
July 28, 2017
Last Update Submitted That Met QC Criteria
June 29, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Nelfinavir
Other Study ID Numbers
- 200802788
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Terminated due to poor enrollment; lack of data to share.
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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