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

This study has been withdrawn prior to enrollment.
(All 29 consented subjects tested negative for the BRCA2 mutation. None started study, so PI decided to close the study.)
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00386399
First received: October 10, 2006
Last updated: May 12, 2014
Last verified: May 2014
  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: 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

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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. [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • To describe the toxicity of MMC in this patient population. [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
  • To explore pharmacogenetic factors that may influence the toxicity and efficacy of MMC in this patient population. [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: October 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Mitomycin C
    Mitomycin C, finds use as a chemotherapeutic agent by virtue of its antitumour antibiotic activity.
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Histological or cytological proven adenocarcinoma of the pancreas.
  2. Locally advanced unresectable or metastatic disease not amenable to curative treatment.
  3. No prior treatment for advanced disease. Patient may have received adjuvant treatment after curative resection. Patients who have received gemcitabine as part of their adjuvant treatment need to have at least a 6 month progression free interval after gemcitabine has been discontinued.
  4. BRCA2 deleterious mutation, or genetic variant, suspected deleterious, by DNA testing.
  5. No prior treatment with MMC.
  6. Age ≥18 years old.
  7. ECOG PS 0-1.
  8. Expected > 12 weeks survival.
  9. Adequate renal, liver and bone-marrow function as determined by:
  10. Ability to understand and willingness to sign a written informed consent.
  11. Willingness of male and female subjects, who are not surgically sterile or post-menopausal, to use reliable methods of birth control (oral contraceptives, intrauterine devices, or barrier methods) for the duration of the study and for 30 days after the last dose of study medication.

Exclusion Criteria

  1. Patients in whom histologic or cytologic diagnosis is not consistent with adenocarcinoma including adenosquamous, islet cell, cystadenoma or cystadenocarcinoma, carcinoid, small or large cell carcinoma or lymphoma.
  2. Adenocarcinoma arising from a site other than pancreas (distal common bile duct, ampulla of vater or periampullary duodenum).
  3. Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  4. Patients who have had any previous surgery, excluding minor procedures, dental work, skin biopsy, etc. within 4 weeks of enrollment.
  5. Uncontrolled medical conditions that could potentially increase the risk of toxicities or complications of this therapy including immunodeficiency and chronic treatment with immunosuppressors. Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease.
  6. Active infections.
  7. History of concurrent malignancy or history of a second malignancy within the past 5 years, except squamous cell and basal cell carcinoma of the skin.
  8. Participation in an investigational new drug trial within one month of starting trial.
  9. Unable to provide informed consent.
  10. Concomitant use of phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital or St. Johns Wort.
  11. Treatment with chemotherapy within 30 days of day 1 treatment.
  12. Any unresolved chronic toxicity greater than CTCAE grade 2 from previous anticancer therapy (except alopecia).
  13. Pregnant women are excluded from this study because the effects of MMC on the developing fetus are not known (FDA Pregnancy Category C). Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with MMC, breast feeding should be discontinued if the mother is treated with the drug.
  14. Patients must not have clinically significant cardiovascular disease including myocardial infarction (within 12 months prior to randomization), unstable angina, grade II or greater peripheral vascular disease, uncontrolled congestive heart failure or uncontrolled hypertension (SBP>170, DBP>95).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386399

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Manuel Hidalgo, MD, PhD Sidney Kimmel Comprehensive Cancer Center
  More Information

No publications provided

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: May 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Advanced Pancreatic Cancer
Mutated BRCA2 Gene
Recurrent Pancreatic Cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Mitomycin
Mitomycins
Alkylating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014