Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005820
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2000-06-02
Brief Title:
Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Study of 9 Nitrocamptothecin for Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of nitrocamptothecin in treating men who have stage IV prostate cancer that has not responded to hormone therapy
PURPOSE Phase II trial to study the effectiveness of nitrocamptothecin in treating men who have stage IV prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES
Determine the therapeutic efficacy of nitrocamptothecin in patients with metastatic hormone refractory prostate cancer
Determine time to disease progression and duration of response in this patient population as a result of this treatment regimen
Determine the safety tolerance and toxicity of this treatment regimen in these patients
OUTLINE Patients receive nitrocamptothecin orally daily for 5 consecutive days each week for 3 consecutive weeks Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until evidence of progression or relapse for a maximum of 2 years from the date of registration
PROJECTED ACCRUAL A total of 22-46 patients will be accrued for this study over 2 years
Determine the therapeutic efficacy of nitrocamptothecin in patients with metastatic hormone refractory prostate cancer
Determine time to disease progression and duration of response in this patient population as a result of this treatment regimen
Determine the safety tolerance and toxicity of this treatment regimen in these patients
OUTLINE Patients receive nitrocamptothecin orally daily for 5 consecutive days each week for 3 consecutive weeks Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until evidence of progression or relapse for a maximum of 2 years from the date of registration
PROJECTED ACCRUAL A total of 22-46 patients will be accrued for this study over 2 years
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 |
|---|---|---|---|
| CDR0000067827 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CLB-99901 | None | None | None |
| GUMC-00192 | None | None | None |