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 : Active, not recruiting
First Posted : April 22, 2010
Last Update Posted : July 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: Nelfinavir||Phase 1|
- 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)|
|Estimated Enrollment :||72 participants|
|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 :||August 2014|
- Drug: 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 [ Time Frame: 10 days of estimated date of treatment completion or requires a treatment break greater than 5 days ]Feasibility will be based on multiple radiation planning and treatment parameters.Treatment will be deemed infeasible if patient cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised. Patient is unable to tolerate 30% of treatments using proton radiotherapy, that is, up to 70% of treatments could be delivered using photons. Patient is unable to complete all of his/her treatments within 10 days of estimated date of treatment completion or require a treatment break greater than 5 days.
- Acute Toxicity (or dose limiting toxicity) [ Time Frame: Greater than 14 days ]Any treatment related Grade 4 hematologic toxicty requiring a break in therapy of greater than 14 days or Grade 3 or higher non-hematologic toxicity, except esophagitis and pneumonitis, which is observed within 90 days from start of radiotherapy and which is probably or definitely related to treatment. All toxicities will be graded by NCI CTC Version 4.0.
- Late Toxicity [ Time Frame: Open-Ended, Known to occur a year or more after therapy ]Late toxicities will be graded according to the RTOG/EORTC late morbidity scoring system. The time frame for late toxicity is open-ended and late toxicities have been known to occur a year or more after therapy. Follow-up for late toxicity will cease when a patient experiences disease progression, since 2nd line therapies may then be initiated.
- Clinical EfficacyDefined 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.
- BiomarkersWill be evaluated on tumor tissue, as the methods for measurement become available. For example, the radiation resistance biomarker, IRDS (Interferon Related DNA Damage Resistance Gene Signature), will soon be under prospective validation in NSCLC. Similar biomarker discoveries will be considered during the course of this 4 1/2.year trial.
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|