Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003762
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2000-05-02
Brief Title:
Docetaxel and Gemcitabine 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:
Randomized Phase II Study of Docetaxel and Gemcitabine for 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 Randomized phase II trial to compare the effectiveness of two regimens of docetaxel plus gemcitabine in treating patients who have stage IIIB or stage IV non-small cell lung cancer
PURPOSE Randomized phase II trial to compare the effectiveness of two regimens of docetaxel plus gemcitabine in treating patients who have stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES I Evaluate the response rate of patients with stage IIIB or IV nonsmall cell lung cancer to different schedules of docetaxel and gemcitabine therapy II Evaluate the toxicity of this treatment in these patients III Describe the quality of life parameters of patients receiving this combination therapy IV Determine the survival rate of these patients
OUTLINE This is a randomized study Patients are stratified by disease stage IIIB vs stage IV and performance status 0 vs 1 Patients are randomized to one of two treatment arms Arm I now closed Arm I Patients receive docetaxel IV over 1 hour on day 1 followed by gemcitabine IV over 30 minutes on days 1 8 and 15 closed as of 8311999 Arm II Patients receive docetaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1 and 15 Arm III Patients receive docetaxel IV on day 1 and gemcitabine IV on days 1 8 and 15 Patients continue treatment every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression Patients with either stable disease or completepartial response who discontinue treatment after 4-6 courses may be eligible for NCCTG-97-24-51 Quality of life is assessed before treatment and before each course of therapy Patients are followed every 3 months for 1 year then every 3 months for 5 years
PROJECTED ACCRUAL A total of 19-53 patients will be accrued for this study within 6-18 months
OUTLINE This is a randomized study Patients are stratified by disease stage IIIB vs stage IV and performance status 0 vs 1 Patients are randomized to one of two treatment arms Arm I now closed Arm I Patients receive docetaxel IV over 1 hour on day 1 followed by gemcitabine IV over 30 minutes on days 1 8 and 15 closed as of 8311999 Arm II Patients receive docetaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1 and 15 Arm III Patients receive docetaxel IV on day 1 and gemcitabine IV on days 1 8 and 15 Patients continue treatment every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression Patients with either stable disease or completepartial response who discontinue treatment after 4-6 courses may be eligible for NCCTG-97-24-51 Quality of life is assessed before treatment and before each course of therapy Patients are followed every 3 months for 1 year then every 3 months for 5 years
PROJECTED ACCRUAL A total of 19-53 patients will be accrued for this study within 6-18 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 |
|---|---|---|---|
| CDR0000066887 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02294 | REGISTRY | None | None |