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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Mitomycin C, finds use as a chemotherapeutic agent by virtue of its antitumour antibiotic activity.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
6-month overall survival
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.
Time frame: up to 6 months
Response rate
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.
Time frame: up to 2.5 years
Progression-free survival at 6 months
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.
Time frame: up to 6 months
Progression-free survival
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.
Time frame: up to 2.5 years
Overall survival
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.
Time frame: up to 2.5 years
Toxicity as assessed by number of participants experiencing adverse events.
Time frame: Up to 2.5 years
To explore pharmacogenetic factors that may influence the toxicity and efficacy of MMC in this patient population.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 2.5 years