Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026377
Status:
COMPLETED
Last Update Posted:
2013-09-05
First Post:
2001-11-09
Brief Title:
SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Phase I Study Of SU5416 With Androgen Ablation And Radiation In Patients With Intermediate and Advanced Stage Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-09
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 SU5416 may stop the growth of cancer by stopping blood flow to the tumor Androgens can stimulate the growth of prostate cancer cells Hormone therapy using flutamide bicalutamide leuprolide or goserelin may fight prostate cancer by reducing the production of androgens Radiation therapy uses high-energy x-rays to damage tumor cells Combining SU5416 hormone therapy and radiation therapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of SU5416 plus hormone therapy and radiation therapy in treating patients who have prostate cancer
PURPOSE Phase I trial to study the effectiveness of SU5416 plus hormone therapy and radiation therapy in treating patients who have prostate cancer
Detailed Description:
OBJECTIVES I Determine the safety of SU5416 in combination with standard androgen ablation and radiotherapy in patients with intermediate or advanced-stage prostate cancer
OUTLINE This is a multicenter dose-escalation study of SU5416 Patients receive oral bicalutamide once daily or oral flutamide three times daily for at least 1 month followed by leuprolide or goserelin subcutaneously once monthly for four months Beginning after the fourth administration of leuprolide or goserelin patients undergo radiotherapy 5 days a week for 7-8 weeks Beginning one month before radiotherapy and continuing until 1 month after radiotherapy patients receive SU5416 IV over 60 minutes on days 1 and 4 Treatment repeats weekly in the absence of disease progression or unacceptable toxicity Cohorts of 3-12 patients receive escalating doses of SU5416 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 3 of 12 patients experience dose-limiting toxicity Patients are followed every 4-6 weeks for 4 months and then every 8-12 weeks for 8 months
PROJECTED ACCRUAL A total of 3-18 patients will be accrued for this study
OUTLINE This is a multicenter dose-escalation study of SU5416 Patients receive oral bicalutamide once daily or oral flutamide three times daily for at least 1 month followed by leuprolide or goserelin subcutaneously once monthly for four months Beginning after the fourth administration of leuprolide or goserelin patients undergo radiotherapy 5 days a week for 7-8 weeks Beginning one month before radiotherapy and continuing until 1 month after radiotherapy patients receive SU5416 IV over 60 minutes on days 1 and 4 Treatment repeats weekly in the absence of disease progression or unacceptable toxicity Cohorts of 3-12 patients receive escalating doses of SU5416 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 3 of 12 patients experience dose-limiting toxicity Patients are followed every 4-6 weeks for 4 months and then every 8-12 weeks for 8 months
PROJECTED ACCRUAL A total of 3-18 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-4390 | None | None | None |
| UCCRC-NCI-4390 | None | None | None |