Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006389
Status:
COMPLETED
Last Update Posted:
2014-10-01
First Post:
2000-10-04
Brief Title:
Bryostatin 1 and Cisplatin in Treating Patients With Metastatic or Unresectable Stomach Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Combination Trial of Bryostatin-1 and Cisplatin in the Treatment of Metastatic Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2013-10
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:
Phase II trial to study the effectiveness of bryostatin 1 and cisplatin in treating patients who have metastatic or unresectable stomach cancer Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Bryostatin 1 may increase the effectiveness of cisplatin by making tumor cells more sensitive to the drug Combining cisplatin with bryostatin 1 may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the response rate and survival in patients with metastatic or unresectable carcinoma of the stomach treated with bryostatin 1 and cisplatin
II Determine the toxic effects of this regimen in these patients III Determine the molecular determinants of response to this regimen in these patients
OUTLINE This is a multicenter study
Patients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1 hour on day 4 Treatment repeats every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity
I Determine the response rate and survival in patients with metastatic or unresectable carcinoma of the stomach treated with bryostatin 1 and cisplatin
II Determine the toxic effects of this regimen in these patients III Determine the molecular determinants of response to this regimen in these patients
OUTLINE This is a multicenter study
Patients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1 hour on day 4 Treatment repeats every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| N01CM17101 | NIH | CTEP | httpsreporternihgovquickSearchN01CM17101 |
| NCI-2012-02361 | REGISTRY | None | None |
| CHNMC-PHII-22 | None | None | None |
| CDR0000068267 | None | None | None |
| NCI-T99-0040 | None | None | None |
| PHII-22 USC 3S-00-1 | OTHER | None | None |
| T99-0040 | OTHER | None | None |