Radiation Therapy, Cisplatin, and Etoposide in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Removed by Surgery
Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Recurrent Non-small Cell Lung Cancer; Stage IIB Non-small Cell Lung Cancer; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer
Intervention: 3-dimensional conformal radiation therapy (Radiation); intensity-modulated radiation therapy (Radiation); cisplatin (Drug); etoposide (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: University of Washington Official(s) and/or principal investigator(s): Shilpen Patel, Principal Investigator, Affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
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 removed by surgery. Radiation therapy uses high energy x rays to kill tumor
cells. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways
to stop the growth of tumor cells, either by killing the cells, by stopping them from
dividing, or by stopping them from spreading. Drugs, such as cisplatin, may make tumor cells
more sensitive to radiation therapy. Giving radiation therapy together with cisplatin and
etoposide may kill more tumor cells.
Clinical Details
Official title: A Phase I Dose-Intensification Study Using Radiation Therapy and Concurrent Cisplatin and Etoposide for Patients With Inoperable Non-small Cell Lung Cancer
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: MTD of radiotherapy, in terms of number of daily fractions, that can be delivered using 3D-CRT or IMRT with the standard cisplatin/etoposide regimen
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
overall treatment time.
OUTLINE: This is a dose-escalation study of radiation therapy.
Patients undergo 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated
radiotherapy (IMRT) 5 days a week for 8 weeks. Patients also receive cisplatin intravenously
(IV) over 60 minutes on days 1, 8, 28, and 36 and etoposide IV over 60 minutes on days 1-5
and 28-32.
After completion of study treatment, patients are followed up at 8 weeks and 6 months.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington 98109, United States; Recruiting Shilpen Patel, Phone: 206-598-4100 Shilpen Patel, Principal Investigator
Additional Information
Starting date: October 2011
Last updated: March 11, 2015
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