Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004139
Status:
COMPLETED
Last Update Posted:
2016-07-20
First Post:
1999-12-10
Brief Title:
Gemcitabine Plus Docetaxel or Irinotecan in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Randomized Trial of GemcitabineDocetaxel and GemcitabineIrinotecan in Stage IIIBIV Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to compare the effectiveness of gemcitabine plus either docetaxel or irinotecan in treating patients who have stage IIIB or stage IV non-small cell lung cancer
PURPOSE Phase II trial to compare the effectiveness of gemcitabine plus either docetaxel or irinotecan in treating patients who have stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES I Compare the complete and overall response rate to gemcitabine and docetaxel versus gemcitabine and irinotecan in chemotherapy naive patients with stage IIIB or IV non-small cell lung cancer II Compare the overall and failure free survival duration of response and toxicity associated with these combination regimens in this patient population
OUTLINE This is a randomized study Patients are stratified according to disease stage stage IIIB vs stage IV without CNS involvement vs stage IV with CNS involvement vs recurrentprogressive disease post surgery andor radiotherapy Patients are randomized to one of two treatment arms Arm I Patients receive gemcitabine IV over 30 minutes immediately followed by irinotecan IV over 90 minutes on days 1 and 8 Arm II Patients receive gemcitabine IV over 30 minutes immediately followed by docetaxel IV over 60 minutes on days 1 and 8 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Patients achieving partial or complete response or stable disease receive treatment for least 6 courses and for 2 additional courses beyond the maximum response and then at the investigators discretion Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter until disease progression or death
PROJECTED ACCRUAL A total of 72 patients 36 per treatment arm will be accrued for this study within 12 months
OUTLINE This is a randomized study Patients are stratified according to disease stage stage IIIB vs stage IV without CNS involvement vs stage IV with CNS involvement vs recurrentprogressive disease post surgery andor radiotherapy Patients are randomized to one of two treatment arms Arm I Patients receive gemcitabine IV over 30 minutes immediately followed by irinotecan IV over 90 minutes on days 1 and 8 Arm II Patients receive gemcitabine IV over 30 minutes immediately followed by docetaxel IV over 60 minutes on days 1 and 8 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Patients achieving partial or complete response or stable disease receive treatment for least 6 courses and for 2 additional courses beyond the maximum response and then at the investigators discretion Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter until disease progression or death
PROJECTED ACCRUAL A total of 72 patients 36 per treatment arm will be accrued for this study within 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 |
|---|---|---|---|
| CDR0000067369 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CLB-39809 | None | None | None |