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

Phase 2

Withdrawn

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Arm 1	Mitomycin-C	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

Primary Outcome Measures

Name	Time	Method
6-month overall survival	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 Outcome Measures

Name	Time	Method
Response rate	up to 2.5 years	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.
Progression-free survival at 6 months	up to 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.
Progression-free survival	up to 2.5 years	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.
Overall survival	up to 2.5 years	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.
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

Locations (1): Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸
Baltimore, Maryland, United States