Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061958
Status:
TERMINATED
Last Update Posted:
2013-01-23
First Post:
2003-06-05
Brief Title:
Arsenic Trioxide in Treating Patients With Advanced Cancer 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 Arsenic Trioxide NSC 706363 in Patients With Advanced Adenocarcinoma of the Esophagus or Gastroesophageal Junction
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial is studying how well arsenic trioxide works in treating patients with metastatic or unresectable cancer of the esophagus or gastroesophageal junction Drugs used in chemotherapy such as arsenic trioxide use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the response rate and duration of response in patients with advanced adenocarcinoma of the esophagus or gastroesophageal junction treated with arsenic trioxide
II Determine the toxicity of this drug in these patients
OUTLINE This is an open-label study
Patients receive a loading dose of arsenic trioxide IV over 2 hours on days 1-5 on week 1 Beginning on week 2 patients receive a maintenance dose of arsenic trioxide IV twice weekly thereafter Courses repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR continue to receive therapy for at least 6 months beyond CR
Patients are followed every 3 months for 6 months or until disease progression
I Determine the response rate and duration of response in patients with advanced adenocarcinoma of the esophagus or gastroesophageal junction treated with arsenic trioxide
II Determine the toxicity of this drug in these patients
OUTLINE This is an open-label study
Patients receive a loading dose of arsenic trioxide IV over 2 hours on days 1-5 on week 1 Beginning on week 2 patients receive a maintenance dose of arsenic trioxide IV twice weekly thereafter Courses repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR continue to receive therapy for at least 6 months beyond CR
Patients are followed every 3 months for 6 months or until disease progression
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 |
|---|---|---|---|
| CDR0000302483 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17003 |
| DM02-172 | None | None | None |
| N01CM17003 | NIH | None | None |