Phase II Study of Mitomycin-C in Patients With Advanced or Recurrent Pancreatic Cancer With Mutated BRCA2 Gene
Overview
- Phase
- Phase 2
- Intervention
- Mitomycin-C
- Conditions
- Pancreatic Cancer
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Locations
- 1
- Primary Endpoint
- 6-month overall survival
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm 1
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
Intervention: Mitomycin-C
Outcomes
Primary Outcomes
6-month overall survival
Time Frame: up to 6 months
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.
Secondary Outcomes
- Response rate(up to 2.5 years)
- Progression-free survival at 6 months(up to 6 months)
- Progression-free survival(up to 2.5 years)
- Overall survival(up to 2.5 years)
- Toxicity as assessed by number of participants experiencing adverse events.(Up to 2.5 years)
- To explore pharmacogenetic factors that may influence the toxicity and efficacy of MMC in this patient population.(2.5 years)