A Study of Erlotinib Plus Radiotherapy (RT) for Patients With Advanced or Inoperable Non-Small-Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00983307
First received: September 22, 2009
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

It is generally accepted that the presence of chronically hypoxic cells, or tumor cells which do not receive enough oxygen as a result of tumor growth, may be an important cause of resistance to radiation therapy (RT) and resultant tumor recurrence, particularly in large tumors such as advanced non-small-cell lung cancer (NSCLC). Therefore, delivering a higher RT dose, as is done with hypofractionated RT, to the tumor may result in higher success rate.

Erlotinib (Tarceva, previously known as OSI-774) is an orally active, potent, selective inhibitor of the Epidermal Growth Factor Receptor (EGFR) tyrosine kinase. A recently completed trial has shown that Erlotinib as a single agent significantly improves the survival of patients with incurable Stage IIIb/IV NSCLC who have failed standard therapy for advanced or metastatic disease. Therefore, Erlotinib is an approved medication for second-line therapy in lung cancer following prior chemotherapy.

This is a Phase II clinical research study to assess the efficacy and toxicity of hypofractionated radiation therapy in combination with Erlotinib in patients with locally advanced or inoperable non-small-cell lung cancer (NSCLC).

The investigators' hypothesis is that the addition of erlotinib to RT will result in radiosensitization, therefore increasing the likelihood of local tumor control over RT alone. Maintenance erlotinib upon RT completion will result in further tumor growth inhibition, both systemically and locally, lengthening disease-free survival and overall survival.


Condition Intervention Phase
Carcinoma, Non-small-cell Lung
Other: Erlotinib plus hypofractionated radiotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Erlotinib (Tarceva) and Hypofractionated Thoracic Radiotherapy for Patients With Advanced or Inoperable Non-Small-Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • To estimate progression-free survival. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: August 2009
Estimated Study Completion Date: October 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib and radiotherapy
Patients will be treated with Erlotinib and hypofractionated radiotherapy.
Other: Erlotinib plus hypofractionated radiotherapy
Patients will receive Tarceva, 150 mg daily on days -5 through -1 days and will start a course of hypofractionated thoracic RT on Day 1. RT will be administered daily on weekdays (Monday-Friday) and not on weekends or holidays. Tarceva administration will be continued daily during RT (also on weekends/holidays when RT is not given) and after RT will be continued daily as maintenance therapy until death or disease progression.
Other Names:
  • Erlotinib (OSI-774)
  • Tarceva
  • RT
  • Radiation Therapy
  • Hypofractionated Radiotherapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must fulfill all of the following criteria to be eligible for study entry:

  • Patients aged 18 years or older with histologically or cytologically confirmed unresectable or medically inoperable NSCLC and measurable disease.
  • Patients with AJC Stage IV (metastatic) NSCLC who need initial thoracic RT to control symptoms such as hemoptysis, airway obstruction, esophageal compression, superior vena cava syndrome, other symptoms, or to prevent symptomatic tumor progression.
  • Patients with synchronous brain metastases will be allowed to enroll and to receive whole-brain radiation therapy while on the protocol.
  • Patients with unresectable or medically inoperable locally advanced (AJC Stage II, IIIA or IIIB) NSCLC, who require thoracic RT but do not qualify for other protocols due to the presence of a malignant pleural or pericardial effusion, major weight loss, poor performance status, unwillingness to receive chemotherapy or other factors.
  • Patients with medically inoperable Stage I NSCLC or those patients with a resectable Stage I NSCLC who decline surgery.
  • Patients treated initially with systemic chemotherapy or biologic therapy who eventually develop progression of intrathoracic disease and require thoracic RT, or who may benefit from consolidative thoracic RT following chemotherapy or biologic therapy.
  • Patients must have a minimal FEV1 of 1.2 l. Lower FEV1 may be allowed for small tumors and a V17 <25%.
  • Estimated life expectancy of 3 months or more.
  • Patients able to provide a written informed consent prior to study entry.
  • Patients who agree to have their biopsy or surgical specimen analyzed for the EGFR status.
  • Women of childbearing potential must be willing to practice acceptable methods of birth control to prevent pregnancy.

Exclusion Criteria:

Any of the following is a criterion for exclusion from the trial:

  • Small cell lung cancer, any stage
  • Previous thoracic radiation therapy
  • Oxygen-dependent patients
  • FEV1 < 1.2 l
  • Patients with severe underlying lung disease of any origin, which in the opinion of the investigators may markedly increase the risk of treatment-related pneumonitis
  • Known severe hypersensitivity to Erlotinib or any of the excipients of this product
  • Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St John's Wort preparations
  • Treatment with a nonapproved or investigational drug within 30 days before Day 1 of trial treatment
  • Incomplete healing from previous oncologic or other major surgery
  • Serum creatinine level greater than CTC grade 2
  • Pregnancy or breast feeding (women of childbearing potential)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00983307

Locations
United States, Pennsylvania
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, United States, 18512
Thomas Jefferson Univeristy
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Genentech
Investigators
Principal Investigator: Maria Werner-Wasik, MD Thomas Jefferson University
  More Information

Additional Information:
No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00983307     History of Changes
Other Study ID Numbers: 09G.104, 2008-43, OSI4327s
Study First Received: September 22, 2009
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
Radiation
Erlotinib
Tarceva

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014