Phase II Study of Mitomycin-C in Patients With Advanced or Recurrent Pancreatic Cancer With Mutated BRCA2 Gene
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
10mg/m2 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 mg/m2.
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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.
2.5 years
No
Manuel Hidalgo, MD, PhD
Study Chair
Sidney Kimmel Comprehensive Cancer Center
United States: Institutional Review Board
J0626
NCT00386399
October 2006
February 2008
Name | Location |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |