Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01411098
First received: August 4, 2011
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 15
Study Start Date: October 2011
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01411098

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Shilpen Patel    206-598-4100      
Principal Investigator: Shilpen Patel         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Shilpen Patel Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01411098     History of Changes
Other Study ID Numbers: 7506, NCI-2011-01752, 7506, P30CA015704
Study First Received: August 4, 2011
Last Updated: September 16, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Cisplatin
Etoposide
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014