Carboplatin, Paclitaxel, Selenomethionine, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
NCT ID: NCT00526890
Last Updated: 2017-11-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
16 participants
INTERVENTIONAL
2006-10-31
2010-09-30
Brief Summary
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PURPOSE: This phase II trial is studying the side effects and how well selenomethionine works when given together with carboplatin, paclitaxel, and radiation therapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.
Detailed Description
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Primary
* Determine the safety and tolerability of selenomethionine in combination with chemotherapy and radiotherapy in patients with unresectable stage IIIA or IIIB non-small cell lung cancer.
* Determine if the incidence of excessive adverse events, in the form of esophagitis, pneumonitis, and myelosuppression, can be reduced with this regimen.
Secondary
* Estimate response rate, failure-free survival, and overall survival of these patients.
* Correlate selenium levels with degree of observed adverse events.
OUTLINE: This is a multicenter study.
Patients receive oral selenomethionine twice daily for 1 week and then once daily for 6 weeks. Patients also receive paclitaxel IV over 1 hour once weekly and carboplatin IV over 30 minutes once weekly for 6 weeks and undergo radiotherapy 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and weekly during treatment and analyzed by absorption spectrophotometry for selenium measurement of drug concentration
After the completion of study treatment, patients are followed periodically.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CPSR
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
selenomethionine
Oral Twice daily
carboplatin
Weekly IV
paclitaxel
Weekly IV
laboratory biomarker analysis
Correlative Study
radiation therapy
Undergoing radiation Therapy
Interventions
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selenomethionine
Oral Twice daily
carboplatin
Weekly IV
paclitaxel
Weekly IV
laboratory biomarker analysis
Correlative Study
radiation therapy
Undergoing radiation Therapy
Eligibility Criteria
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Inclusion Criteria
* No prior taxanes or platinum drugs
* No other concurrent investigational agents or anticancer therapy
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent chemotherapy or hormonal therapy, except for the following:
* Steroids administered for adrenal failure or septic shock
* Hormones administered for non-disease-related conditions (e.g., insulin for diabetes)
* Glucocorticosteroids administered as antiemetics
18 Years
120 Years
ALL
No
Sponsors
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Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Jorge Gomez, MD
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Other Identifiers
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RPCI-I-65605
Identifier Type: -
Identifier Source: secondary_id
CDR0000562780
Identifier Type: -
Identifier Source: org_study_id