Study to Evaluate Using Nelfinavir With Chemoradiation for Non-small Cell Lung Cancer
Tracking Information | |||||
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First Received Date ICMJE | November 13, 2008 | ||||
Last Updated Date | August 9, 2010 | ||||
Start Date ICMJE | August 2008 | ||||
Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Pathologic complete response [ Time Frame: 30 days ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00791336 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Study to Evaluate Using Nelfinavir With Chemoradiation for Non-small Cell Lung Cancer | ||||
Official Title ICMJE | 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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Carcinoma, Non-Small-Cell Lung | ||||
Intervention ICMJE | Drug: Nelfinavir
1250 mg twice daily starting for approximately 6.5 weeks.
Other Name: Viracept |
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Study Arm (s) | Experimental: Nelfinavir
Intervention: Drug: Nelfinavir |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Estimated Enrollment ICMJE | 66 | ||||
Estimated Completion Date | August 2014 | ||||
Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00791336 | ||||
Other Study ID Numbers ICMJE | 200802788 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Anjali K. Gupta, M.D., Department of Radiation Oncology | ||||
Study Sponsor ICMJE | University of Iowa | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | University of Iowa | ||||
Verification Date | August 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |