Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064051
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2003-07-08
Brief Title:
3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
Sponsor:
Vion Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2008-08
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 gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and may help gemcitabine kill more cancer cells by making them more sensitive to the drug
PURPOSE This phase II trial is studying how well giving gemcitabine together with 3-AP works in treating patients with unresectable or metastatic pancreatic cancer
PURPOSE This phase II trial is studying how well giving gemcitabine together with 3-AP works in treating patients with unresectable or metastatic pancreatic cancer
Detailed Description:
OBJECTIVES
Determine the objective response rate partial and complete response in patients with unresectable or metastatic pancreatic cancer treated with 3-AP and gemcitabine
Determine the progression-free interval and survival of patients treated with this regimen
Determine the safety and feasibility of this regimen in these patients
OUTLINE This is a multicenter study
Stage I Patients receive 3-AP IV over 4 hours and gemcitabine IV over 30 minutes on days 1 8 and 15 Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity
Stage II Patients receive a higher dose of 3-AP IV continuously over 24 hours on days 1 8 and 15 Within 1 hour of completing 3-AP administration patients receive gemcitabine IV over 30 minutes on days 2 9 and 16 Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 month every 2 months for 6 months and then every 3 months for 18 months
PROJECTED ACCRUAL A total of 50-95 patients will be accrued for this study within 18-24 months
Determine the objective response rate partial and complete response in patients with unresectable or metastatic pancreatic cancer treated with 3-AP and gemcitabine
Determine the progression-free interval and survival of patients treated with this regimen
Determine the safety and feasibility of this regimen in these patients
OUTLINE This is a multicenter study
Stage I Patients receive 3-AP IV over 4 hours and gemcitabine IV over 30 minutes on days 1 8 and 15 Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity
Stage II Patients receive a higher dose of 3-AP IV continuously over 24 hours on days 1 8 and 15 Within 1 hour of completing 3-AP administration patients receive gemcitabine IV over 30 minutes on days 2 9 and 16 Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 month every 2 months for 6 months and then every 3 months for 18 months
PROJECTED ACCRUAL A total of 50-95 patients will be accrued for this study within 18-24 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000306461 | REGISTRY | PDQ Physician Data Query | None |