Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003326
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
1999-11-01
Brief Title:
Paclitaxel in Treating Patients With Metastatic Recurrent or Unresectable Cancer of the Esophagus
Sponsor:
Theradex
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Paclitaxel TAXOL Administered as a Weekly One Hour Infusion in Patients With Advanced Esophageal Cancer
Status:
UNKNOWN
Status Verified Date:
2001-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of paclitaxel in treating patients with metastatic recurrent or unresectable cancer of the esophagus
PURPOSE Phase II trial to study the effectiveness of paclitaxel in treating patients with metastatic recurrent or unresectable cancer of the esophagus
Detailed Description:
OBJECTIVES I Determine the objective response rate of paclitaxel administered as a weekly one hour infusion in patients with metastatic locally recurrent or unresectable squamous cell carcinoma and adenocarcinoma of the esophagus II Evaluate the safety of paclitaxel in this patient population III Assess the overall survival and quality of life of these patients
OUTLINE This is an open label multicenter study Patients receive intravenous paclitaxel over 1 hour weekly Each course consists of four weeks Patients receive treatment until disease progression or unacceptable toxic effects is observed Patient response is assessed every 2 courses during the first year and then every 3 months in subsequent years Quality of life is assessed prior to treatment prior to each course for 6 courses then every 2 courses Patients are followed every 3 months until death
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study
OUTLINE This is an open label multicenter study Patients receive intravenous paclitaxel over 1 hour weekly Each course consists of four weeks Patients receive treatment until disease progression or unacceptable toxic effects is observed Patient response is assessed every 2 courses during the first year and then every 3 months in subsequent years Quality of life is assessed prior to treatment prior to each course for 6 courses then every 2 courses Patients are followed every 3 months until death
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study
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-V98-1414 | None | None | None |
| THERADEX-B97-4250 | None | None | None |
| BMS-TAXMEN04 | None | None | None |
| MSKCC-98018 | None | None | None |
| NYU-9801 | None | None | None |