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.
Verified March 2013 by Fred Hutchinson Cancer Research Center
Sponsor:
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01411098
First received: August 4, 2011
Last updated: March 19, 2013
Last verified: March 2013
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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 or by stopping them from dividing. 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 Fred Hutchinson Cancer Research Center:
Primary Outcome Measures:
- Maximum tolerated dose 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 (DLT). Toxicity will be scored using the National Cancer Institute (NCI) Common Toxicity Criteria version 4.0.
| Estimated Enrollment: | 15 |
| Study Start Date: | October 2011 |
| Estimated Primary Completion Date: | September 2013 (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:
Radiation: intensity-modulated radiation therapy
Undergo IMRT
Other Name: IMRT
Drug: cisplatin
Given IV
Other Names:
Drug: etoposide
Given IV
Other Names:
|
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
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 206-598-3300 | |
| Principal Investigator: Shilpen Patel | |
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Investigators
| Principal Investigator: | Shilpen Patel | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01411098 History of Changes |
| Other Study ID Numbers: | 7506, NCI-2011-01752, P30CA015704 |
| Study First Received: | August 4, 2011 |
| Last Updated: | March 19, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Etoposide phosphate Cisplatin Etoposide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 19, 2013