Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030641
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2002-02-14
Brief Title:
Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer
Sponsor:
Genta Incorporated
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Study of Docetaxel Versus Docetaxel Plus Genasense G3139 Bcl-2 Antisense Oligonucleotide in Patients With Previously Treated Non-Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2003-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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 docetaxel use different ways to stop tumor cells from dividing so they stop growing or die Oblimersen may increase the effectiveness of docetaxel by making the tumor cells more sensitive to the drug It is not yet known if docetaxel is more effective with or without oblimersen in treating non-small cell lung cancer
PURPOSE Randomized phase IIIII trial to compare the effectiveness of docetaxel with or without oblimersen in treating patients who have relapsed or refractory non-small cell lung cancer that has been previously treated
PURPOSE Randomized phase IIIII trial to compare the effectiveness of docetaxel with or without oblimersen in treating patients who have relapsed or refractory non-small cell lung cancer that has been previously treated
Detailed Description:
OBJECTIVES
Compare the survival of patients with non-small cell lung cancer treated with docetaxel with or without oblimersen G3139
Compare the proportion of major antitumor responses in patients treated with these regimens
Compare the response duration and time to progression in patients treated with these regimens
Compare the safety and clinical benefit of these regimens in terms of changes in performance status and tumor-related symptoms in these patients
Compare the proportion of patients surviving 6 and 12 months after treatment with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to response to prior first-line chemotherapy regimen progression vs stable disease partial response or complete response ECOG performance status 0-1 vs 2 and prior paclitaxel treatment yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oblimersen G3139 IV continuously on days 1-7 and docetaxel IV over 1 hour on day 5 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity Patients with responding or stable disease upon completion of 8 courses may receive 8 or more additional courses at physicians discretion
Arm II Patients receive docetaxel IV over 1 hour on day 1 Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity Upon completion of 8 courses patients may continue to receive docetaxel off study at physicians discretion
Patients are followed every 9 weeks for up to 18 months
PROJECTED ACCRUAL A total of 280 patients 140 per treatment arm will be accrued for this study
Compare the survival of patients with non-small cell lung cancer treated with docetaxel with or without oblimersen G3139
Compare the proportion of major antitumor responses in patients treated with these regimens
Compare the response duration and time to progression in patients treated with these regimens
Compare the safety and clinical benefit of these regimens in terms of changes in performance status and tumor-related symptoms in these patients
Compare the proportion of patients surviving 6 and 12 months after treatment with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to response to prior first-line chemotherapy regimen progression vs stable disease partial response or complete response ECOG performance status 0-1 vs 2 and prior paclitaxel treatment yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oblimersen G3139 IV continuously on days 1-7 and docetaxel IV over 1 hour on day 5 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity Patients with responding or stable disease upon completion of 8 courses may receive 8 or more additional courses at physicians discretion
Arm II Patients receive docetaxel IV over 1 hour on day 1 Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity Upon completion of 8 courses patients may continue to receive docetaxel off study at physicians discretion
Patients are followed every 9 weeks for up to 18 months
PROJECTED ACCRUAL A total of 280 patients 140 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCLA-0301058 | None | None | None |
| GENTA-GN304 | None | None | None |
| NCI-G01-2046 | None | None | None |