Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00526890
Status:
TERMINATED
Last Update Posted:
2017-11-28
First Post:
2007-09-07
Brief Title:
Carboplatin Paclitaxel Selenomethionine and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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:
OBJECTIVES
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RPCI-I-65605 | None | None | None |