Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070486
Status:
COMPLETED
Last Update Posted:
2016-06-30
First Post:
2003-10-03
Brief Title:
Carboplatin and Gemcitabine Combined With Celecoxib andor Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Randomized Phase II Study of Eicosanoid Pathway Modulators and Cytotoxic Chemotherapy in Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die Celecoxib and zileuton may stop the growth of tumor cells by stopping blood flow to the tumor and may block the enzymes necessary for tumor cell growth Combining chemotherapy with celecoxib andor zileuton may kill more tumor cells
PURPOSE Randomized phase II trial to study the effectiveness of combining celecoxib andor zileuton with carboplatin and gemcitabine in treating patients who have advanced non-small cell lung cancer
PURPOSE Randomized phase II trial to study the effectiveness of combining celecoxib andor zileuton with carboplatin and gemcitabine in treating patients who have advanced non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Compare the efficacy of carboplatin and gemcitabine with celecoxib andor zileuton in terms of 7-month progression-free survival in patients with advanced non-small cell lung cancer
Secondary
Compare the response rate distribution of survival and failure-free survival time of patients treated with these regimens
Correlate CYFRA and serum vascular endothelial growth factor levels with response and survival of patients treated with these regimens
Correlate cyclo-oxygenase-2 and 5-lipoxygenase expression with survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive gemcitabine IV over 30 minutes on days 1 and 8 carboplatin IV over 30 minutes on day 1 and oral zileuton 4 times daily on days 1-21
Arm II Patients receive gemcitabine and carboplatin as in arm I and oral celecoxib twice daily on days 1-21
Arm III Patients receive gemcitabine and carboplatin as in arm I oral celecoxib as in arm II and oral zileuton as in arm I
In all arms treatment repeats every 21 days for 6 courses Patients with responding or stable disease continue courses of zileuton andor celecoxib in the absence of disease progression or unacceptable toxicity
Patients are followed monthly for 1 year every 2 months for 2 years and then every 4 months for 3 years or until disease progression
PROJECTED ACCRUAL A total of 117 patients 39 per treatment arm will be accrued for this study within 11-12 months
Primary
Compare the efficacy of carboplatin and gemcitabine with celecoxib andor zileuton in terms of 7-month progression-free survival in patients with advanced non-small cell lung cancer
Secondary
Compare the response rate distribution of survival and failure-free survival time of patients treated with these regimens
Correlate CYFRA and serum vascular endothelial growth factor levels with response and survival of patients treated with these regimens
Correlate cyclo-oxygenase-2 and 5-lipoxygenase expression with survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive gemcitabine IV over 30 minutes on days 1 and 8 carboplatin IV over 30 minutes on day 1 and oral zileuton 4 times daily on days 1-21
Arm II Patients receive gemcitabine and carboplatin as in arm I and oral celecoxib twice daily on days 1-21
Arm III Patients receive gemcitabine and carboplatin as in arm I oral celecoxib as in arm II and oral zileuton as in arm I
In all arms treatment repeats every 21 days for 6 courses Patients with responding or stable disease continue courses of zileuton andor celecoxib in the absence of disease progression or unacceptable toxicity
Patients are followed monthly for 1 year every 2 months for 2 years and then every 4 months for 3 years or until disease progression
PROJECTED ACCRUAL A total of 117 patients 39 per treatment arm will be accrued for this study within 11-12 months
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 |
|---|---|---|---|
| CDR0000334573 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CALGB-30203 | None | None | None |