Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003677
Status:
COMPLETED
Last Update Posted:
2018-10-25
First Post:
1999-11-01
Brief Title:
Dolastatin 10 in Treating Patients With Metastatic Pancreatic Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of Dolastatin 10 NSC 376128 Administered Intravenously Every 21 Days to Patients With Metastatic Pancreatic Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2018-10
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:
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 dolastatin 10 in treating patients who have metastatic pancreatic cancer
PURPOSE Phase II trial to study the effectiveness of dolastatin 10 in treating patients who have metastatic pancreatic cancer
Detailed Description:
OBJECTIVES I Assess the antitumor activity of dolastatin 10 in patients with metastatic adenocarcinoma of the pancreas II Evaluate the qualitative and quantitative toxic effects of this therapy in these patients III Investigate the clinical pharmacology of this treatment
OUTLINE This is an open label multicenter study Patients receive dolastatin 10 IV bolus once every 21 days Treatment continues in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months until death
PROJECTED ACCRUAL This study will accrue 12-37 patients within 185 months
OUTLINE This is an open label multicenter study Patients receive dolastatin 10 IV bolus once every 21 days Treatment continues in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months until death
PROJECTED ACCRUAL This study will accrue 12-37 patients within 185 months
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 |
|---|---|---|---|
| P30CA016672 | NIH | None | None |
| U01CA070172 | NIH | None | None |
| U01CA063187 | NIH | None | None |
| MDA-DM-98071 | OTHER | None | None |
| NCI-T98-0028 | None | None | None |
| CDR0000066778 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchU01CA063187 |