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| Sponsor: | Sidney Kimmel Comprehensive Cancer Center |
|---|---|
| Information provided by (Responsible Party): | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00386399 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: Mitomycin C |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Phase II Study of Mitomycin-C in Patients With Advanced or Recurrent Pancreatic Cancer With Mutated BRCA2 Gene |
| Enrollment: | 29 |
| Study Start Date: | October 2006 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
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:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate renal, liver and bone-marrow function as determined by:
WBC greater than or equal to 3,500 cells/mm3 ANC greater than or equal to 1,500 cells/mm3 Platelets greater than or equal to 100,000 cells/mm3 Hemoglobin greater than or equal to 9 g/dl Serum creatinine equal or less than 2.0 mg/dl Bilirubin equal or less than 2 mg/dL ALT, AST, and alkaline phosphatase equal or less than 5 times the upper limit of normal
Exclusion Criteria:
Contacts and Locations| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21205 | |
| Study Chair: | Manuel Hidalgo, MD, PhD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00386399 History of Changes |
| Other Study ID Numbers: | J0626, NA_00002002 |
| Study First Received: | October 10, 2006 |
| Last Updated: | February 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Advanced Pancreatic Cancer Mutated BRCA2 Gene Recurrent Pancreatic Cancer |
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Mitomycins |
Mitomycin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Alkylating Agents |