Proton Beam Radiation With Concurrent Chemotherapy and Nelfinavir for Inoperable Stage III Non Small Cell Lung Cancer (NSCLC)
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|ClinicalTrials.gov Identifier: NCT01108666|
Recruitment Status : Terminated (Insufficient accrual)
First Posted : April 22, 2010
Last Update Posted : June 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: Nelfinavir||Phase 2|
- Determine MTD of proton beam radiotherapy with concurrent cisplatin and etoposide for stage III NSCLC.
- Determine MTD of proton beam radiotherapy with concurrent carboplatin and paclitaxel for stage III NSCLC in non-cisplatin candidates.
- Determine MTD of Nelfinavir with concurrent chemoradiotherapy for stage III NSCLC at RPTD of proton beam radiotherapy.
- Develop biomarker for clinical outcome with concurrent chemoradiotherapy in stage III NSCLC.
- To determine clinical efficacy, as defined by metabolic response, sites of recurrence (e.g., local, regional, distant) and progression-free and overall survival.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Dose Escalation Trial of Proton Beam Radiotherapy With Concurrent Chemotherapy and Nelfinavir for Inoperable Stage III NSCLC|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||July 2018|
|Actual Study Completion Date :||December 2018|
|Experimental: Proton RT and Nelfinavir||
Two dose levels of Nelfinavir will be evaluated in each concurrent chemotherapy group (carboplatin/paclitaxel and cisplatin/etoposide) at the RPTD does of proton beam radiotherapy: 625 and 1250 mg PO bid.
- Feasibility of proton radiation [ Time Frame: 10 days ]Ability to successfully plan proton plans
- Acute Toxicity (or dose limiting toxicity) [ Time Frame: 14 days ]Dose limiting toxicities of grade 3 or higher per CTCAE 4.0
- Late Toxicity [ Time Frame: 5 years ]Late toxicities graded according to the RTOG/EORTC late morbidity scale
- Clinical Efficacy [ Time Frame: One year ]Defined as metabolic response (complete, partial or less than partial) based on PET/CT imaging. Patients are followed for disease recurrence and site (local, regional, distant). Progression-free and overall survival are defined as from start of treatment to first documented recurrence (for PFS), date of death or last patient contact alive.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108666
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|