Status:
COMPLETED
A Study of Erlotinib Plus Radiotherapy (RT) for Patients With Advanced or Inoperable Non-Small-Cell Lung Cancer
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Carcinoma, Non-small-cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 radia...
Detailed Description
Hypothesis/Rationale: Lung cancer is the number one cause of cancer-related mortality in both men and women in the United States, with over 170,000 cases diagnosed annually. The overall 5-year surviva...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 27 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00983307
Start Date
August 27 2009
End Date
December 1 2012
Last Update
April 30 2025
Active Locations (2)
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1
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, United States, 18512
2
Thomas Jefferson Univeristy
Philadelphia, Pennsylvania, United States, 19107