Status:
TERMINATED
Radiation Therapy, Cisplatin, and Etoposide in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Removed by Surgery
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent Non-small Cell Lung Cancer
Stage IIB Non-small Cell Lung Cancer
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
This phase I trial studies the side effects and best dose of radiation therapy when given together with cisplatin and etoposide in treating patients with non-small cell lung cancer that cannot be remo...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of escalating doses of radiotherapy (RT) administered concomitantly with a fixed dose of cisplatin and etoposide within the same o...
Eligibility Criteria
Inclusion
- Patients with confirmed unresectable Stage IIB or Stage III non-small cell lung cancer of any histologic-subtype appropriate for definitive concurrent chemotherapy and radiation as determined by multi-disciplinary assessment; all detectable tumor should be encompassable by radiation therapy fields, including both the primary tumor and the involved regional lymph nodes
- Granulocytes \>= 1500/ul
- Platelets \>= 100,000/ul
- Bilirubin \< 1.5 mg/dl
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) \< 2 upper limit of normal (ULN)
- Creatinine clearance must be \> 60ml/min
- Eastern Cooperative Oncology Group (ECOG) 0 to 1
- Weight loss =\< 5% in the previous six months unless weight loss is intentional (per judgment of study medical doctor \[MD\])
- Forced expiratory volume in one second (FEV1) must be \>= 1.0 L
- Patients must sign a study-specific informed consent form prior to study entry
- Patients must have measurable disease on the 3D planning computed tomography (CT)
- Patient must have a completed 3D plan and the attending physician must have reviewed and approved the dose volume histograms as follows: total lung volume percentage receiving at least 20 Gy (V20) =\< 35%, and mean lung dose =\< 20 Gy
Exclusion
- Mixed histology or undifferentiated small cell carcinoma, any stage
- Concurrent malignancy except non-melanomatous skin cancer or prior cancer if disease-free for one year or more
- Patients with malignant pleural effusions or significant pericardial effusions
- Pregnant or lactating females
- Severe neuropathy greater than or equal to grade 2
- Severe sensorineural hearing loss greater or equal to grade 2
- No clinically significant history of cardiac disease, (i.e. uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the past year, or cardiac ventricular arrhythmias requiring medication)
- Any significant or severe medical conditions or psychiatric or social conditions that would preclude adherence to the protocol or compliance with study treatments
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01411098
Start Date
October 1 2011
Last Update
November 4 2015
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109