Carboplatin, Paclitaxel, Selenomethionine, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
|ClinicalTrials.gov Identifier: NCT00526890|
Recruitment Status : Terminated (lack of efficacy)
First Posted : September 10, 2007
Results First Posted : January 15, 2015
Last Update Posted : November 28, 2017
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Selenomethionine may slow the growth of tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with selenomethionine and radiation therapy may kill more tumor cells.
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Dietary Supplement: selenomethionine Drug: carboplatin Drug: paclitaxel Other: laboratory biomarker analysis Radiation: radiation therapy||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination With Radiation for Patients With Unresectable Stage III Non-Small Cell Lung Cancer: A Phase II, Multi-Center Trial|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||September 2010|
U.S. FDA Resources
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
Dietary Supplement: selenomethionine
Oral Twice dailyDrug: carboplatin
Weekly IVDrug: paclitaxel
Weekly IVOther: laboratory biomarker analysis
Correlative StudyRadiation: radiation therapy
Undergoing radiation Therapy
- Incidence of Grade 3-4 Esophagitis [ Time Frame: During study treatment, up to 6 weeks ]
- Incidence of Grade 3-4 Pneumonitis [ Time Frame: During study treatment, up to 6 weeks ]
- Incidence of Grade 3-4 Myelosuppression [ Time Frame: During study treatment, up to 6 weeks ]
- Response Rate [ Time Frame: 1 month post-treatment, then q 3 months x 4 ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Failure-free Survival [ Time Frame: Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter. ]
- Overall Survival [ Time Frame: Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter ]
- Selenium Level by Incidence of SAE [ Time Frame: Pre-treatment and every week for 6 weeks prior to chemotherapy. ]Median Selenium level by Incidence of SAE. Mann-Whitney-Wilcoxon test was used to test the correlation between selenium levels and serious adverse events.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00526890
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Jorge Gomez, MD||Roswell Park Cancer Institute|