Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080782
Status:
TERMINATED
Last Update Posted:
2018-10-31
First Post:
2004-04-07
Brief Title:
Doxorubicin and Strontium-89 With or Without Celecoxib in Treating Patients With Progressive Androgen-Independent Prostate Cancer and Bone Metastases
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Randomized Phase II Trial of Bone-Targeted Therapy Consisting of Strontium-89 and Doxorubicin With or Without Celecoxib in Androgen-Independent Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual due to competing trial
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 doxorubicin work in different ways to stop tumor cells from dividing so they stop growing or die Strontium-89 may relieve bone pain caused by prostate cancer Celecoxib may stop the growth of cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth Combining doxorubicin and strontium-89 with celecoxib may kill more tumor cells
PURPOSE This randomized phase II trial is studying celecoxib together with doxorubicin and strontium-89 to see how well they work compared to doxorubicin and strontium-89 alone in treating patients with progressive androgen-independent prostate cancer and bone metastases
PURPOSE This randomized phase II trial is studying celecoxib together with doxorubicin and strontium-89 to see how well they work compared to doxorubicin and strontium-89 alone in treating patients with progressive androgen-independent prostate cancer and bone metastases
Detailed Description:
OBJECTIVES
Compare time to prostate-specific antigen progression in patients with progressive androgen-independent prostate cancer and bone metastases treated with doxorubicin and strontium chloride Sr 89 with or without celecoxib
OUTLINE This is a randomized study Patients are stratified according to extent of bone metastases on bone scan 20 lesions vs 20 lesions and quality of response ie decline of the prostate-specific antigen from baseline to prior induction chemotherapy 80 vs 80 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive doxorubicin IV over 30 minutes on days 1 8 15 and 22 and strontium chloride Sr 89 IV on day 1 Patients also receive oral celecoxib twice daily in the absence of disease progression
Arm II Patients receive doxorubicin and strontium chloride Sr 89 as in arm I
PROJECTED ACCRUAL A total of 70 patients 35 per treatment arm will be accrued for this study within 18 months
Compare time to prostate-specific antigen progression in patients with progressive androgen-independent prostate cancer and bone metastases treated with doxorubicin and strontium chloride Sr 89 with or without celecoxib
OUTLINE This is a randomized study Patients are stratified according to extent of bone metastases on bone scan 20 lesions vs 20 lesions and quality of response ie decline of the prostate-specific antigen from baseline to prior induction chemotherapy 80 vs 80 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive doxorubicin IV over 30 minutes on days 1 8 15 and 22 and strontium chloride Sr 89 IV on day 1 Patients also receive oral celecoxib twice daily in the absence of disease progression
Arm II Patients receive doxorubicin and strontium chloride Sr 89 as in arm I
PROJECTED ACCRUAL A total of 70 patients 35 per treatment arm will be accrued for this study within 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 |
|---|---|---|---|
| CDR0000355360 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| P50CA090270 | NIH | None | None |
| P30CA016672 | NIH | None | None |
| MDA-ID-02035 | OTHER | None | None |