Pancreatic Cancer Clinical Trial
Official title:
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 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.
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