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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. Treatment will continue until disease progression, serious toxicity, patient withdrawal or maximum cumulative dose of 60 mg/m2

Mitomycin C, finds use as a chemotherapeutic agent by virtue of its antitumour antibiotic activity.

Mitomycin-C

Manuel Hidalgo, MD, PhD

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.

Study of Mitomycin-C in Patients With Advanced or Recurrent Pancreatic Cancer With Mutated BRCA2 Gene

Phase II Study of Mitomycin-C in Patients With Advanced or Recurrent Pancreatic Cancer With Mutated BRCA2 Gene

Number of participants with previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations that are alive after 6-months after being treated with single agent Mitomycin-C (MMC) chemotherapy.

Proportion of participants with reduction in tumor burden of previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations who are treated with single agent MMC chemotherapy.

Number of participants who are treated with single agent MMC chemotherapy and have partial or complete response of previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations.

Number of participants with previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations who are alive after being treated with single agent MMC chemotherapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Mitomycin-C in Patients With Advanced or Recurrent Pancreatic Cancer With Mutated BRCA2 Gene	NCT00386399	Pancreatic Canc...	Mitomycin-C	18 Years - 100 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study of Mitomycin-C in Patients With Advanced or Recurrent Pancreatic Cancer With Mutated BRCA2 Gene	NCT00386399	Pancreatic Canc...	Mitomycin-C	18 Years - 100 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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