Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078975
Status:
COMPLETED
Last Update Posted:
2018-09-14
First Post:
2004-03-08
Brief Title:
3-AP and Gemcitabine in Treating Patients With Recurrent Unresectable or Metastatic Pancreatic Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Phase II Study of Triapine in Combination With Gemcitabine in RecurrentUnresectableMetastatic Pancreatic Carcinoma
Status:
COMPLETED
Status Verified Date:
2018-09
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 Drugs used in chemotherapy such as 3-AP and gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die 3-AP may help gemcitabine kill more tumor cells by making them more sensitive to the drug
PURPOSE This phase II trial is studying how well giving 3-AP together with gemcitabine works in treating patients with recurrent unresectable or metastatic pancreatic cancer
PURPOSE This phase II trial is studying how well giving 3-AP together with gemcitabine works in treating patients with recurrent unresectable or metastatic pancreatic cancer
Detailed Description:
OBJECTIVES
Primary
Determine the antitumor activity of 3-AP Triapine and gemcitabine in terms of complete and partial response and 6-month progression-free disease in patients with recurrent unresectable or metastatic pancreatic cancer
Secondary
Determine the objective response rates median survival 1-year survival rate duration of response or stable disease and progression-free survival of patients treated with this regimen
Determine the safety and tolerability of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive 3-AP Triapine IV over 2 hours and gemcitabine IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity Patients achieving a complete or partial response receive an additional 2 courses of therapy beyond response
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 28-50 patients will be accrued for this study within 7-13 months
Primary
Determine the antitumor activity of 3-AP Triapine and gemcitabine in terms of complete and partial response and 6-month progression-free disease in patients with recurrent unresectable or metastatic pancreatic cancer
Secondary
Determine the objective response rates median survival 1-year survival rate duration of response or stable disease and progression-free survival of patients treated with this regimen
Determine the safety and tolerability of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive 3-AP Triapine IV over 2 hours and gemcitabine IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity Patients achieving a complete or partial response receive an additional 2 courses of therapy beyond response
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 28-50 patients will be accrued for this study within 7-13 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 |
|---|---|---|---|
| NCI-6271 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000353205 | REGISTRY | None | None |