Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077545
Status:
COMPLETED
Last Update Posted:
2013-10-08
First Post:
2004-02-10
Brief Title:
3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Of Triapine In Combination With Cisplatin Esophageal Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-10
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:
Drugs used in chemotherapy such as 3-AP and cisplatin work in different ways to stop tumor cells from dividing so they stop growing or die 3-AP may help cisplatin kill more cancer cells by making them more sensitive to the drug This phase II trial is studying how well giving 3-AP together with cisplatin works in treating patients with recurrent or metastatic adenocarcinoma of the esophagus or gastroesophageal junction
Detailed Description:
PRIMARY OBJECTIVES
I Determine the objective response rate in patients with recurrent or metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with 3-AP Triapine and cisplatin
SECONDARY OBJECTIVES
I Determine the toxicity of this regimen in these patients II Determine the duration of response and overall survival of patients treated with this regimen
III Determine the palliative benefits with regard to dysphagia in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive 3-AP Triapine IV over 2 hours on days 1-4 Patients also receive cisplatin IV over 60 minutes on days 2 and 3 before 3-AP infusion Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed for up to 2 years
PROJECTED ACCRUAL A total of 19-39 patients will be accrued for this study within 20 months
I Determine the objective response rate in patients with recurrent or metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with 3-AP Triapine and cisplatin
SECONDARY OBJECTIVES
I Determine the toxicity of this regimen in these patients II Determine the duration of response and overall survival of patients treated with this regimen
III Determine the palliative benefits with regard to dysphagia in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive 3-AP Triapine IV over 2 hours on days 1-4 Patients also receive cisplatin IV over 60 minutes on days 2 and 3 before 3-AP infusion Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed for up to 2 years
PROJECTED ACCRUAL A total of 19-39 patients will be accrued for this study within 20 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 |
|---|---|---|---|
| N01CM62201 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62201 |
| NCI-2012-02576 | REGISTRY | None | None |
| CDR0000352307 | None | None | None |
| UCCRC-12765A | None | None | None |
| NCI-6285 | None | None | None |
| 12765A | OTHER | None | None |
| 6285 | OTHER | None | None |