Back to resultsProton Beam Radiation With Concurrent Chemotherapy and Nelfinavir for Inoperable Stage III Non Small Cell Lung Cancer (NSCLC)
Primary Purpose
Non Small Cell Lung Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nelfinavir
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Stage IIIA or IIIB NSCLC
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of NSCLC.
- Stage IIIA or IIIB NSCLC.
- Patients must have no evidence of metastatic disease based on routine imaging.
- Patients must have a Karnofsky Performance Status of 60.
- Age 18 and older.
- Patients must be able to provide informed consent.
- Adequate bone marrow function (i.e. WBC larger than or equal to 4000/mm3, platelets larger than or equal to 100,000 mm3).
- Adequate renal function for cisplatin or carboplatin as determined by the medical oncologist: Usually Calculated creatinine clearance (CrCl) larger than or equal to 45 mL/min or serum creatinine level smaller than or equal to1.5 x institutional ULN.
- Patients must have bilirubin 1.5 mg/dl.
- Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc).
- Hysterectomy or menopause must be clinically documented.
Exclusion Criteria:
- Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma or melanoma in situ).
- Pregnant women, women planning to become pregnant and women that are nursing.
- Actively being treated on any other research study.
- For the Nelfinavir phase of the trial only: Patients who are taking Antiarrhythmics (amiodarone, quinidine), Antimycobacterial (rifampin), Ergot Derivatives (dihydroergotamine, ergonovine, ergotamine, ethylergonovine), Herbal Products (St. John's wort/ hypericum perforatum), HMG-CoA Reductase Inhibitors (lovastatin, simvastatin), Neuroleptic (pimozide), Proton Pump Inhibitors, or Sedative/ Hypnotics (midazolam, triazolam). Note: Patients with the following conditions are deemed unsuitable for cisplatin-based chemotherapy (and will be treated with carboplatin): (a) Hearing impairment/ peripheral neuropathy Grade 1 or less at baseline (b) Symptomatic/uncontrolled congestive heart failure (unable to tolerate volume load with pre- and post-cisplatin hydration)
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Proton RT and Nelfinavir
Arm Description
Outcomes
Primary Outcome Measures
Feasibility of Proton Radiation
Ability to successfully plan proton plans
Acute Toxicity (or Dose Limiting Toxicity)
Dose limiting toxicities of grade 3 or higher per CTCAE 4.0
Late Toxicity
Late toxicities graded according to the RTOG/EORTC late morbidity scale
Secondary Outcome Measures
Clinical Efficacy
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.
Full Information
NCT ID
NCT01108666
First Posted
April 12, 2010
Last Updated
July 2, 2021
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01108666
Brief Title
Proton Beam Radiation With Concurrent Chemotherapy and Nelfinavir for Inoperable Stage III Non Small Cell Lung Cancer (NSCLC)
Official Title
Phase I Dose Escalation Trial of Proton Beam Radiotherapy With Concurrent Chemotherapy and Nelfinavir for Inoperable Stage III NSCLC
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Insufficient accrual
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Seventy two patients are being asked to take part in this research study because they have been diagnosed with Stage IIIA or IIIB non-small cell lung cancer (NSCLC). This study is being done to determine the highest safe dose of proton beam radiotherapy and/or study drug (called Nelfinavir) that can be given with concurrent chemoradiotherapy to patients with cancer without causing bad side effects; and to develop biomarker for clinical outcome. This study will be done in two phases. In the first phase, feasibility will be established. We will follow patients treatment courses and record side effects at the standard proton radiation dose that can be given together with Cisplatinum + Etoposide or Carboplatin + Paclitaxel. In the second phase, we will see if it is possible to increase the total proton radiation dose or study drug without increasing the number of bad side effects while treated together with chemotherapy drugs.
Detailed Description
Overall objectives:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
Stage IIIA or IIIB NSCLC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Proton RT and Nelfinavir
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nelfinavir
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of Proton Radiation
Description
Ability to successfully plan proton plans
Time Frame
10 days
Title
Acute Toxicity (or Dose Limiting Toxicity)
Description
Dose limiting toxicities of grade 3 or higher per CTCAE 4.0
Time Frame
14 days
Title
Late Toxicity
Description
Late toxicities graded according to the RTOG/EORTC late morbidity scale
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Clinical Efficacy
Description
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.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of NSCLC.
Stage IIIA or IIIB NSCLC.
Patients must have no evidence of metastatic disease based on routine imaging.
Patients must have a Karnofsky Performance Status of 60.
Age 18 and older.
Patients must be able to provide informed consent.
Adequate bone marrow function (i.e. WBC larger than or equal to 4000/mm3, platelets larger than or equal to 100,000 mm3).
Adequate renal function for cisplatin or carboplatin as determined by the medical oncologist: Usually Calculated creatinine clearance (CrCl) larger than or equal to 45 mL/min or serum creatinine level smaller than or equal to1.5 x institutional ULN.
Patients must have bilirubin 1.5 mg/dl.
Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc).
Hysterectomy or menopause must be clinically documented.
Exclusion Criteria:
Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma or melanoma in situ).
Pregnant women, women planning to become pregnant and women that are nursing.
Actively being treated on any other research study.
For the Nelfinavir phase of the trial only: Patients who are taking Antiarrhythmics (amiodarone, quinidine), Antimycobacterial (rifampin), Ergot Derivatives (dihydroergotamine, ergonovine, ergotamine, ethylergonovine), Herbal Products (St. John's wort/ hypericum perforatum), HMG-CoA Reductase Inhibitors (lovastatin, simvastatin), Neuroleptic (pimozide), Proton Pump Inhibitors, or Sedative/ Hypnotics (midazolam, triazolam). Note: Patients with the following conditions are deemed unsuitable for cisplatin-based chemotherapy (and will be treated with carboplatin): (a) Hearing impairment/ peripheral neuropathy Grade 1 or less at baseline (b) Symptomatic/uncontrolled congestive heart failure (unable to tolerate volume load with pre- and post-cisplatin hydration)
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Proton Beam Radiation With Concurrent Chemotherapy and Nelfinavir for Inoperable Stage III Non Small Cell Lung Cancer (NSCLC)
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