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| Sponsor: | Sidney Kimmel Comprehensive Cancer Center |
|---|---|
| Information provided by: | 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 II |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
| Official Title: | Phase II Study of Mitomycin-C in Patients With Advanced or Recurrent Pancreatic Cancer With Mutated BRCA2 Gene |
| Estimated Enrollment: | 35 |
| Study Start Date: | October 2006 |
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 at Johns Hopkins ( Manuel Hidalgo, M.D., PhD ) |
| Study ID Numbers: | J0626, NA_00002002 |
| Study First Received: | October 10, 2006 |
| Last Updated: | December 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00386399 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Advanced Pancreatic Cancer Mutated BRCA2 Gene Recurrent Pancreatic Cancer |
|
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Endocrine System Diseases Enzyme Inhibitors Antibiotics, Antineoplastic Mitomycins Pharmacologic Actions |
Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Mitomycin Pancreatic Diseases Alkylating Agents Nucleic Acid Synthesis Inhibitors Endocrine Gland Neoplasms |