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

NCT ID: NCT01411098

Last Updated: 2015-11-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

3-dimensional conformal radiation therapy

Intervention Type: RADIATION

Undergo 3D-CRT

intensity-modulated radiation therapy

Intervention Type: RADIATION

Undergo IMRT

cisplatin

Intervention Type: DRUG

Given IV

etoposide

Intervention Type: DRUG

Given IV

Interventions

3-dimensional conformal radiation therapy

Undergo 3D-CRT

Intervention Type: RADIATION

intensity-modulated radiation therapy

Undergo IMRT

Intervention Type: RADIATION

cisplatin

Given IV

Intervention Type: DRUG

etoposide

Given IV

Intervention Type: DRUG

Other Intervention Names

3D conformal radiation therapy; 3D-CRT; IMRT; CACP; CDDP; CPDD; DDP; EPEG; VP-16; VP-16-213

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shilpen Patel

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Locations

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, United States

Countries

United States

Other Identifiers

NCI-2011-01752

Identifier Type: REGISTRY

Identifier Source: secondary_id

7506

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

7506

Identifier Type: -

Identifier Source: org_study_id