Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005599
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
2000-05-02
Brief Title:
Bryostatin 1 Plus Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer or Stomach Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trail of Bryostatin-1 and Paclitaxel in Patients With Advanced Esophageal Cancer
Status:
COMPLETED
Status Verified Date:
2004-08
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of bryostatin 1 and paclitaxel in treating patients who have locally advanced or metastatic esophageal cancer or stomach cancer
PURPOSE Phase II trial to study the effectiveness of bryostatin 1 and paclitaxel in treating patients who have locally advanced or metastatic esophageal cancer or stomach cancer
Detailed Description:
OBJECTIVES
Determine the complete and partial response rates in patients with unresectable or metastatic esophageal cancer or carcinoma of the gastroesophageal junction treated with sequential paclitaxel and bryostatin 1
Determine the toxicity of this regimen in this patient population
Determine the survival of patients after treatment with this regimen
Determine the quality of life of patients treated with this regimen
Examine pre- and post-treatment tissue biopsies for markers of apoptosis in selected patients
OUTLINE This is a multicenter study
Patients receive paclitaxel IV over 1 hour on day 1 and bryostatin 1 IV over 24 hours on day 2 weekly for 2 weeks Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
Quality of life is assessed at baseline after courses 1 and 2 and then after every 2 courses thereafter
PROJECTED ACCRUAL A total of 19-33 patients will be accrued for this study within 1-2 years
Determine the complete and partial response rates in patients with unresectable or metastatic esophageal cancer or carcinoma of the gastroesophageal junction treated with sequential paclitaxel and bryostatin 1
Determine the toxicity of this regimen in this patient population
Determine the survival of patients after treatment with this regimen
Determine the quality of life of patients treated with this regimen
Examine pre- and post-treatment tissue biopsies for markers of apoptosis in selected patients
OUTLINE This is a multicenter study
Patients receive paclitaxel IV over 1 hour on day 1 and bryostatin 1 IV over 24 hours on day 2 weekly for 2 weeks Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
Quality of life is assessed at baseline after courses 1 and 2 and then after every 2 courses thereafter
PROJECTED ACCRUAL A total of 19-33 patients will be accrued for this study within 1-2 years
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 |
|---|---|---|---|
| NCI-250 | None | None | None |
| MSKCC-99094 | None | None | None |
| MSKCC-FDR001826 | None | None | None |