Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016900
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2001-06-06
Brief Title:
PNU-93914 in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Multicenter Study of the Efficacy and Safety Study of PNU-93914 Liposome Encapsulated Paclitaxel in Patients With Advanced Esophageal Cancer Previously Exposed to Chemotherapy
Status:
COMPLETED
Status Verified Date:
2013-06
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 use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of PNU-93914 in treating patients who have locally advanced or metastatic cancer of the esophagus
PURPOSE Phase II trial to study the effectiveness of PNU-93914 in treating patients who have locally advanced or metastatic cancer of the esophagus
Detailed Description:
OBJECTIVES I Determine the antitumor activity and duration of activity of PNU-93914 in patients with locally advanced or metastatic esophageal carcinoma II Determine the objective tumor response rate and tumor response duration in patients treated with this drug III Determine the survival of patients treated with this drug IV Determine the safety profile of this drug in these patients V Determine the effect of this drug on the quality of life of these patients VI Determine the time to tumor response time to tumor progression and time to treatment failure in patients treated with this drug VII Evaluate the change in dysphagia score in patients treated with this drug
OUTLINE This is a multicenter study Patients receive PNU-93914 IV over 60 minutes on day 1 Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline day 1 of each course and then at the final study visit Patients are followed every 3 months for up to 2 years
PROJECTED ACCRUAL A total of 21-41 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive PNU-93914 IV over 60 minutes on day 1 Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline day 1 of each course and then at the final study visit Patients are followed every 3 months for up to 2 years
PROJECTED ACCRUAL A total of 21-41 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-G01-1946 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068614 | REGISTRY | None | None |
| P-UPJOHN-914-ONC-0355-009 | None | None | None |