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
18 Years
N/A
Both
Carcinoma, Non-Small-Cell Lung
Trial Information
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 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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pathologic complete response
Outcome Time Frame:
30 days
Safety Issue:
No
Principal Investigator
Anjali K Gupta, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
The University of Iowa
Authority:
United States: Institutional Review Board
Study ID:
200802788
NCT ID:
NCT00791336
Start Date:
August 2008
Completion Date:
August 2014
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- NSCLC
- chemotherapy
- radiation therapy
- nelfinavir
- NFV
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| The University of Iowa Department of Radiation Oncology | Iowa City, Iowa 52242 |
