Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006081
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
2000-08-03
Brief Title:
Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study of Bryostatin-1 NSC 339555 Plus Paclitaxel in Patients With Metastatic or Unresectable Locally Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction
Status:
COMPLETED
Status Verified Date:
2012-07
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 combining bryostatin 1 and paclitaxel in treating patients who have unresectable locally advanced or metastatic stomach cancer
PURPOSE Phase II trial to study the effectiveness of combining bryostatin 1 and paclitaxel in treating patients who have unresectable locally advanced or metastatic stomach cancer
Detailed Description:
OBJECTIVES
Determine the response rate in patients with unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with bryostatin 1 and paclitaxel
Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients
OUTLINE Patients receive paclitaxel IV over 1 hour on days 1 8 and 15 and bryostatin 1 IV over 1 hour on days 2 9 and 16 Treatment continues every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients with a complete response CR receive up to 4 more courses after achieving CR
Patients are followed until death
PROJECTED ACCRUAL A total of 18-35 patients will be accrued for this study
Determine the response rate in patients with unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with bryostatin 1 and paclitaxel
Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients
OUTLINE Patients receive paclitaxel IV over 1 hour on days 1 8 and 15 and bryostatin 1 IV over 1 hour on days 2 9 and 16 Treatment continues every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients with a complete response CR receive up to 4 more courses after achieving CR
Patients are followed until death
PROJECTED ACCRUAL A total of 18-35 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 |
|---|---|---|---|
| U01CA070172 | NIH | None | None |
| P30CA016672 | NIH | None | None |
| MDA-ID-99203 | OTHER | None | None |
| NCI-T99-0103 | None | None | None |
| CDR0000068069 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |