Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386399
Status:
WITHDRAWN
Last Update Posted:
2018-07-12
First Post:
2006-10-10
Brief Title:
Study of Mitomycin-C in Patients With Advanced or Recurrent Pancreatic Cancer With Mutated BRCA2 Gene
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Phase II Study of Mitomycin-C in Patients With Advanced or Recurrent Pancreatic Cancer With Mutated BRCA2 Gene
Status:
WITHDRAWN
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
All consented subjects tested negative for the BRCA2 mutation therefore did not meet criteria to start the study resulting in withdrawal by PI
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients will be tested for mutations in the BRCA2 gene If they have a BRCA2 mutation they will be treated with Mitomycin-C as described here The patients with an identified gene mutation will also be provided with genetic counseling
Detailed Description:
Patients will be tested for mutations in the BRCA2 gene If they have a BRCA2 mutation they will be treated with Mitomycin-C as described here The patients with an identified gene mutation will also be provided with genetic counseling
Patients with BRCA2 gene will be treated with Mitomycin-C MMC on Day 1 at a dose of 10mgm2 intravenously This will be repeated every 28 days which is one cycle Expected adverse events and appropriate dose modifications are described in this section Treatment will continue until disease progression serious toxicity patient withdrawal or maximum cumulative dose of 60 mgm2
Primary Objectives
1 To determine the 6-month survival of patients with previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations that are treated with single agent Mitomycin-C MMC chemotherapy
Secondary Objectives
1 To determine the response rate six-month progression free survival rate progression-free survival and survival of patients with previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations who are treated with single agent MMC chemotherapy
2 To describe the toxicity of MMC in this patient population
3 To explore pharmacogenetic factors that may influence the toxicity and efficacy of MMC in this patient population
Patients with BRCA2 gene will be treated with Mitomycin-C MMC on Day 1 at a dose of 10mgm2 intravenously This will be repeated every 28 days which is one cycle Expected adverse events and appropriate dose modifications are described in this section Treatment will continue until disease progression serious toxicity patient withdrawal or maximum cumulative dose of 60 mgm2
Primary Objectives
1 To determine the 6-month survival of patients with previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations that are treated with single agent Mitomycin-C MMC chemotherapy
Secondary Objectives
1 To determine the response rate six-month progression free survival rate progression-free survival and survival of patients with previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations who are treated with single agent MMC chemotherapy
2 To describe the toxicity of MMC in this patient population
3 To explore pharmacogenetic factors that may influence the toxicity and efficacy of MMC in this patient population
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 |
|---|---|---|---|
| NA_00002002 | OTHER | JHMIRB | None |