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

• Sponsor: University of Iowa (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00791336
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Arm: 1
• Duration (Months): 30.9
• Patients Per Site Per Month: 0

Study Details

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
• 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: Aug 1, 2008
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pathologic Complete Response [30 days]

Secondary Outcome Measures

1. Characterization of Overall and Disease-free Survival [long-term]

2. Safety and Tolerability of the Combined Treatment Regimen [7 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	The University of Iowa Department of Radiation Oncology	Iowa City	Iowa	United States	52242

Sponsors and Collaborators

• University of Iowa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Iowa
• ClinicalTrials.gov Identifier: NCT00791336
• Other Study ID Numbers: 200802788
• First Posted: Nov 14, 2008
• Last Update Posted: Jul 28, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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; Nelfinavir

Study Results

Participant Flow

Arm/Group Title	Nelfinavir
Arm/Group Description	Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
Period Title: Overall Study
STARTED	1
COMPLETED	1
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Nelfinavir
Arm/Group Description	Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
Overall Participants	1
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	1 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	1 100%

Outcome Measures

1. Primary Outcome

Title	Pathologic Complete Response
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Only 1 subject was enrolled and treated. Study was terminated due to poor enrollment. Data were not collected or analyzed due to study termination and low enrollment count (n=1).

Arm/Group Title	Nelfinavir
Arm/Group Description	Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
Measure Participants	0

2. Secondary Outcome

Title	Characterization of Overall and Disease-free Survival
Time Frame	long-term

Outcome Measure Data

Analysis Population Description

Only 1 subject was enrolled and treated. Study was terminated due to poor enrollment. Data were not collected or analyzed due to study termination and low enrollment count (n=1).

Arm/Group Title	Nelfinavir
Arm/Group Description	Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
Measure Participants	0

3. Secondary Outcome

Title	Safety and Tolerability of the Combined Treatment Regimen
Time Frame	7 weeks

Outcome Measure Data

Analysis Population Description

Only 1 subject was enrolled and treated. Study was terminated due to poor enrollment. Data were not collected or analyzed due to study termination and low enrollment count (n=1).

Arm/Group Title	Nelfinavir
Arm/Group Description	Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
Measure Participants	0

Adverse Events

Time Frame	Collected through therapy (approximately 6 weeks)
Arm/Group Title	Nelfinavir
Arm/Group Description	Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
All Cause Mortality
	Nelfinavir
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Nelfinavir
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Other (Not Including Serious) Adverse Events
	Nelfinavir
	Affected / at Risk (%)	# Events
Total	0/1 (0%)

Limitations/Caveats

There was only one treated participant. Conclusions cannot be drawn from these data due to limited sampling size.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.