Radiation Therapy, Cisplatin, and Etoposide in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 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.

Condition or disease	Intervention/treatment	Phase
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	Radiation: 3-dimensional conformal radiation therapy; Radiation: intensity-modulated radiation therapy; Drug: cisplatin; Drug: etoposide	Phase 1

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	6 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	October 2011
Actual Primary Completion Date :	March 2015

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Treatment (radiation therapy and chemotherapy); Patients undergo 3D-CRT or IMRT 5 days a week for 8 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 28, and 36 and etoposide IV over 60 minutes on days 1-5, and 28-32.	Radiation: 3-dimensional conformal radiation therapy; Undergo 3D-CRT; Other Names: 3D conformal radiation therapy; 3D-CRT Radiation: intensity-modulated radiation therapy; Undergo IMRT; Other Name: IMRT Drug: cisplatin; Given IV; Other Names: CACP; CDDP; CPDD; DDP Drug: etoposide; Given IV; Other Names: EPEG; VP-16; VP-16-213

Outcome Measures

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Primary Outcome Measures :

1. 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 [ Time Frame: Up to 8 weeks after completion of radiotherapy ]
   The MTD will be the highest dose at which no more than one of six patients experience a dose-limiting toxicity. Toxicity will be scored using the National Cancer Institute Common Toxicity Criteria version 4.0.

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109

Sponsors and Collaborators

University of Washington

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Shilpen Patel	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Washington
ClinicalTrials.gov Identifier:	NCT01411098 History of Changes
Other Study ID Numbers:	7506; NCI-2011-01752 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 7506 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium ); P30CA015704 ( U.S. NIH Grant/Contract )
First Posted:	August 8, 2011
Last Update Posted:	November 4, 2015
Last Verified:	November 2015

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms	Etoposide phosphate; Cisplatin; Etoposide; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action