Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004859
Status:
TERMINATED
Last Update Posted:
2014-06-02
First Post:
2000-03-07
Brief Title:
Carboplatin Paclitaxel and Radiation Therapy With or Without Thalidomide in Patients With Stage III Non-small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase III Trial of Carboplatin Paclitaxel and Thoracic Radiotherapy With or Without Thalidomide in Patients With Stage III Non-Small Cell Lung Cancer NSCLC
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial was stopped early for futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized phase III trial is studying carboplatin paclitaxel radiation therapy and thalidomide to see how well they work compared to carboplatin paclitaxel and radiation therapy alone in treating patients with newly diagnosed stage III non-small cell lung cancer Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Thalidomide may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor It is not yet known if combination chemotherapy plus radiation therapy is more effective with or without thalidomide
Detailed Description:
OBJECTIVES
I Compare the survival and time to progression of patients with stage IIIA or IIIB non-small cell lung cancer when treated with carboplatin paclitaxel and chemoradiotherapy with or without thalidomide
II Evaluate the toxicity of the thalidomide-containing regimen and compare response rates of the two groups
III Determine whether the inactivation of p16 Death-associated protein kinase DAP-kinase O6-methylguanine-DNA methyltransferase MGMT gene or tissue-inhibitor of metalloproteinase 3 TIMP-3 genes can be used to predict survival in these patients treated with this regimen
IV Determine whether the detection of a methylation biomarker in serum can be used to predict survival in these patients treated with this regimen
OUTLINE This is a randomized study Patients are stratified according to disease histology squamous vs nonsquamous performance status 0 vs 1 disease stage IIIA vs IIIB and time of randomization before addition of chemoradiotherapy vs after Patients are randomized to one of two treatment arms
ARM A Patients receive paclitaxel intravenously IV over 3 hours immediately followed by carboplatin IV over 15-30 minutes on days 1 and 22 Treatment continues every 22 days in the absence of unacceptable toxicity or disease progression
ARM B Patients receive paclitaxel and carboplatin as in arm A Patients also receive oral thalidomide and oral low-dose aspirin daily beginning on day 1 for up to 24 months in the absence of disease progression
Beginning between days 43-50 patients in both arms with stable or responding disease receive chemoradiotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 15-30 minutes once weekly for 6 weeks and radiotherapy RT 5 days a week for 6 weeks Arm B patients continue oral thalidomide
Patients are followed every 2 months for 2 years and then every 6 months for 3 years
I Compare the survival and time to progression of patients with stage IIIA or IIIB non-small cell lung cancer when treated with carboplatin paclitaxel and chemoradiotherapy with or without thalidomide
II Evaluate the toxicity of the thalidomide-containing regimen and compare response rates of the two groups
III Determine whether the inactivation of p16 Death-associated protein kinase DAP-kinase O6-methylguanine-DNA methyltransferase MGMT gene or tissue-inhibitor of metalloproteinase 3 TIMP-3 genes can be used to predict survival in these patients treated with this regimen
IV Determine whether the detection of a methylation biomarker in serum can be used to predict survival in these patients treated with this regimen
OUTLINE This is a randomized study Patients are stratified according to disease histology squamous vs nonsquamous performance status 0 vs 1 disease stage IIIA vs IIIB and time of randomization before addition of chemoradiotherapy vs after Patients are randomized to one of two treatment arms
ARM A Patients receive paclitaxel intravenously IV over 3 hours immediately followed by carboplatin IV over 15-30 minutes on days 1 and 22 Treatment continues every 22 days in the absence of unacceptable toxicity or disease progression
ARM B Patients receive paclitaxel and carboplatin as in arm A Patients also receive oral thalidomide and oral low-dose aspirin daily beginning on day 1 for up to 24 months in the absence of disease progression
Beginning between days 43-50 patients in both arms with stable or responding disease receive chemoradiotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 15-30 minutes once weekly for 6 weeks and radiotherapy RT 5 days a week for 6 weeks Arm B patients continue oral thalidomide
Patients are followed every 2 months for 2 years and then every 6 months for 3 years
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 |
|---|---|---|---|
| CDR0000067510 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA021115 |
| U10CA021115 | NIH | None | None |
| E3598 | OTHER | None | None |