Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075660
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2004-01-09
Brief Title:
3-AP in Treating Patients With Previously Untreated Locally Recurrent or Metastatic Renal Cell Carcinoma
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase II Study of Triapine NSC 663249 in Previously Untreated Patients With Recurrent Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2020-04
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 Drugs used in chemotherapy such as 3-AP work in different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of 3-AP in treating patients who have locally recurrent or metastatic renal cell kidney carcinoma cancer
PURPOSE Phase II trial to study the effectiveness of 3-AP in treating patients who have locally recurrent or metastatic renal cell kidney carcinoma cancer
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of 3-AP Triapine in terms of objective response rate in patients with previously untreated locally recurrent or metastatic renal cell carcinoma
Secondary
Determine the adverse events and tolerability of this drug in these patients
Determine the time to disease progression and overall survival of patients treated with this drug
OUTLINE This is a nonrandomized multicenter study
Patients receive 3-AP Triapine IV over 2 hours on days 1-4 and 15-18 Treatment repeats every 28 days for up to 6 courses for stable patients in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR receive 1 additional course after documentation of CR Patients who achieve a partial response PR receive 2 additional courses after documentation of stable PR
Patients are followed every 4 weeks until relapse and then every 3 months for up to 2 years
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 1 year
Primary
Determine the efficacy of 3-AP Triapine in terms of objective response rate in patients with previously untreated locally recurrent or metastatic renal cell carcinoma
Secondary
Determine the adverse events and tolerability of this drug in these patients
Determine the time to disease progression and overall survival of patients treated with this drug
OUTLINE This is a nonrandomized multicenter study
Patients receive 3-AP Triapine IV over 2 hours on days 1-4 and 15-18 Treatment repeats every 28 days for up to 6 courses for stable patients in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR receive 1 additional course after documentation of CR Patients who achieve a partial response PR receive 2 additional courses after documentation of stable PR
Patients are followed every 4 weeks until relapse and then every 3 months for up to 2 years
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000347409 | OTHER | PDQ | None |
| CAN-NCIC-IND161 | OTHER | None | None |