Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087165
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2004-07-08
Brief Title:
GTI-2040 Docetaxel and Prednisone in Treating Patients With Prostate Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Phase II Study of GTI-2040 in Combination With Docetaxel and Prednisone in Hormone-Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2021-04
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 GTI-2040 may stop the growth of tumor cells by blocking the enzymes necessary for their growth Drugs used in chemotherapy such as docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die GTI-2040 may help docetaxel kill more tumor cells by making them more sensitive to the drug
PURPOSE This phase II trial is studying how well giving GTI-2040 together with docetaxel and prednisone works in treating patients with prostate cancer that has not responded to hormone therapy
PURPOSE This phase II trial is studying how well giving GTI-2040 together with docetaxel and prednisone works in treating patients with prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of GTI-2040 docetaxel and prednisone in terms of prostate-specific antigen PSA response rate in patients with hormone-refractory prostate cancer
Secondary
Determine objective tumor response in patients treated with this regimen
Determine the median time to progression in patients treated with this regimen
Determine the safety and tolerability of this regimen in these patients
Determine the median duration of PSA response in patients treated with this regimen
Correlate baseline and post-treatment levels of ribonucleotide reductase activity in tumor biopsies and peripheral blood mononuclear cells and tumoral expression of c-myc R2 subunit protein and markers of cellular proliferation and apoptosis with clinical outcomes in patients treated with this regimen
OUTLINE This is an open-label multicenter study
Patients receive GTI-2040 IV continuously on days 1-14 docetaxel IV on day 3 of course 1 and on day 1 of subsequent courses and oral prednisone twice daily on days 1-21 Treatment repeats every 21 days for up to 10 courses in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 18-46 patients will be accrued for this study within 36-95 months
Primary
Determine the efficacy of GTI-2040 docetaxel and prednisone in terms of prostate-specific antigen PSA response rate in patients with hormone-refractory prostate cancer
Secondary
Determine objective tumor response in patients treated with this regimen
Determine the median time to progression in patients treated with this regimen
Determine the safety and tolerability of this regimen in these patients
Determine the median duration of PSA response in patients treated with this regimen
Correlate baseline and post-treatment levels of ribonucleotide reductase activity in tumor biopsies and peripheral blood mononuclear cells and tumoral expression of c-myc R2 subunit protein and markers of cellular proliferation and apoptosis with clinical outcomes in patients treated with this regimen
OUTLINE This is an open-label multicenter study
Patients receive GTI-2040 IV continuously on days 1-14 docetaxel IV on day 3 of course 1 and on day 1 of subsequent courses and oral prednisone twice daily on days 1-21 Treatment repeats every 21 days for up to 10 courses in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 18-46 patients will be accrued for this study within 36-95 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 |
|---|---|---|---|
| CDR0000372951 | REGISTRY | None | None |
| NCI-6102 | Registry Identifier | PDQ Physician Data Query | None |