Proton Beam Radiation With Concurrent Chemotherapy and Nelfinavir for Inoperable Stage III Non Small Cell Lung Cancer (NSCLC)

NCT01108666 | Terminated Phase 2 Results DMC

• 1 other identifier: UPCC 01510
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Stage IIIA or IIIB NSCLC

Outcome Measures

Primary Outcomes (3)

• Feasibility of Proton Radiation

  Ability to successfully plan proton plans

  10 days

• Acute Toxicity (or Dose Limiting Toxicity)

  Dose limiting toxicities of grade 3 or higher per CTCAE 4.0

  14 days

• Late Toxicity

  Late toxicities graded according to the RTOG/EORTC late morbidity scale

  5 years

Secondary Outcomes (1)

• Clinical Efficacy

  One year

Study Arms (1)

Proton RT and Nelfinavir

EXPERIMENTAL

Drug: Nelfinavir

Interventions

Nelfinavir DRUG

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.

Proton RT and Nelfinavir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nelfinavir

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Abigail Berman
• Organization: University of Pennsylvania

Abigail.Berman@uphs.upenn.edu

215-615-3659

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 22, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 7, 2021
• Results First Posted: October 19, 2020

Record last verified: 2021-07

Locations

US (1)