Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074022
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2003-12-10
Brief Title:
GTI-2040 and Docetaxel in Treating Patients With Recurrent Metastatic or Unresectable Locally Advanced Non-Small Cell Lung Cancer Prostate Cancer or Other Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I2 Study of GTI-2040 Combined With Docetaxel In Metastatic Or Unresectable Locally Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase III trial to study the effectiveness of combining GTI-2040 with docetaxel in treating patients who have recurrent metastatic or unresectable locally advanced non-small cell lung cancer prostate cancer or other solid tumors GTI-2040 may stop the growth of cancer cells by blocking the enzymes necessary for their growth It may also increase the effectiveness of docetaxel by making the tumor cells more sensitive to the drug Combining GTI-2040 with docetaxel may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the recommended phase II dose of GTI-2040 and docetaxel in patients with recurrent metastatic or unresectable locally advanced non-small cell lung cancer prostate cancer or other solid tumors phase I study closed to accrual as of 852004
II Determine the toxicity of this regimen in these patients III Determine the objective tumor response rate in patients treated with this regimen
IV Determine the stable disease rate time to disease progression objective response duration and duration of stable disease in patients treated with this regimen
V Determine the pharmacokinetics of GTI-2040 when administered in combination with docetaxel in these patients
VI Correlate the pharmacokinetics of GTI-2040 with the biological and toxic effects of this regimen in these patients
VII Correlate baseline and post-treatment levels of ribonucleotide reductase activity in tumor biopsies and peripheral blood mononuclear cells and tumoral expression of c-myc ras pRAF1 pMAPK and markers of apoptosis with clinical outcome in patients treated with this regimen
OUTLINE This is an open-label dose-escalation multicenter study
Phase I closed to accrual as of 852004 Patients receive GTI-2040 IV continuously on days 1-14 Patients also receive docetaxel IV over 1 hour on day 3 during course 1 and on day 1 for all subsequent courses Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of GTI-2040 and docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity The recommended phase II dose RP2D is defined as the dose preceding the MTD
Phase II Patients receive GTI-2040 and docetaxel at the RP2D as in phase I
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 12-48 patients 12-18 for phase I closed to accrual as of 852004 and 15-30 for phase II will be accrued for this study within 4-16 months
I Determine the recommended phase II dose of GTI-2040 and docetaxel in patients with recurrent metastatic or unresectable locally advanced non-small cell lung cancer prostate cancer or other solid tumors phase I study closed to accrual as of 852004
II Determine the toxicity of this regimen in these patients III Determine the objective tumor response rate in patients treated with this regimen
IV Determine the stable disease rate time to disease progression objective response duration and duration of stable disease in patients treated with this regimen
V Determine the pharmacokinetics of GTI-2040 when administered in combination with docetaxel in these patients
VI Correlate the pharmacokinetics of GTI-2040 with the biological and toxic effects of this regimen in these patients
VII Correlate baseline and post-treatment levels of ribonucleotide reductase activity in tumor biopsies and peripheral blood mononuclear cells and tumoral expression of c-myc ras pRAF1 pMAPK and markers of apoptosis with clinical outcome in patients treated with this regimen
OUTLINE This is an open-label dose-escalation multicenter study
Phase I closed to accrual as of 852004 Patients receive GTI-2040 IV continuously on days 1-14 Patients also receive docetaxel IV over 1 hour on day 3 during course 1 and on day 1 for all subsequent courses Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of GTI-2040 and docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity The recommended phase II dose RP2D is defined as the dose preceding the MTD
Phase II Patients receive GTI-2040 and docetaxel at the RP2D as in phase I
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 12-48 patients 12-18 for phase I closed to accrual as of 852004 and 15-30 for phase II will be accrued for this study within 4-16 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 |
|---|---|---|---|
| PMH-PHL-017 | None | None | None |
| N01CM17107 | NIH | None | None |
| CDR0000341677 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17107 |