Phase I Trial of 5-Azacitidine Plus Gemcitabine in Patients With Advanced Pancreatic Cancer

This study is currently recruiting participants.
Verified February 2013 by University of Oklahoma
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01167816
First received: July 21, 2010
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

The primary objective is to determine the maximum tolerated dose (MTD) of azacitidine and gemcitabine in subjects with previously untreated and unresectable pancreatic cancer. Also to determine the effect of azacitidine therapy on DNA methylation in peripheral blood cells.


Condition Intervention Phase
Pancreatic Cancer
Drug: Vidaza
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of 5-Azacitidine Plus Gemcitabine in Patients With Advanced Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Determine maximum tolerated dose [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    There will be 5 planned cohorts that will receive the escalating doses of azicitidine and gemcitabine. There will be at least 3 patients in each cohort

  • Toxicity [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    To describe the toxicity associated with the use of this combination regimen


Secondary Outcome Measures:
  • Determine the effect of azacitidine therapy on DNA methylation in peripheral blood cells [ Time Frame: unknown ] [ Designated as safety issue: No ]
    Perform multivariable regression models to explore and assess associations among changes in DNA methylation in peripheral blood cells, chemo effect on tumor (stable disease or shrinkage based on scans) and changes in tumor markers.


Estimated Enrollment: 30
Study Start Date: July 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: azacitabine Drug: Vidaza
Vidaza will be administered subq daily for 5 consecutive days each 28-day cycle
Other Name: Azacitibine

Detailed Description:

This is a Phase I single arm study designed for subjects with newly diagnosed, unresectable pancreatic cancer who have received no prior chemotherapy, radiation therapy, or surgery with curative intent for pancreatic cancer.

  Eligibility

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

Inclusion Criteria:

  • Patient must have pathologically confirmed diagnosis of pancreatic adenocarcinoma
  • Must have measurable disease as defined by RECIST. RECIST evaluation must have occurred within 4 weeks prior to study entry
  • Must have newly diagnosed, unresectable disease and have received no prior chemotherapy, radiation therapy or surgery with curative intent for pancreatic cancer
  • Karnofsky performance status of greater than or equal to 70%
  • Other significant medical conditions must be well controlled and stable in the opinion of the investigator for at least 30 days prior to Study Day 1
  • Women of child bearing age must have negative serum pregnancy test prior to treatment

Exclusion Criteria:

  • Known central nervous system tumor involvement
  • Evidence of other active malignancy requiring treatment
  • Clinically significant heart disease
  • Active serious systemic disease, including active bacterial or fungal infection
  • Active viral hepatitis or symptomatic HIV infection. Positive serology alone is not exclusionary
  • Prior surgery with curative intent for pancreatic cancer
  • Prior or current chemotherapy or radiation therapy for pancreatic cancer. Palliative radiation for distant metastases (excluding metastases in the abdominal region) is allowed
  • Breast feeding, pregnant, or likely to become pregnant during the study
  • known or suspected hypersensitivity to azacitidine or mannitol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167816

Contacts
Contact: Osama Qubaiah, MD 405-271-4022 osama-qubaiah@ouhsc.edu
Contact: Melissa Yarbrough, RN 405-271-8777 melissa-yarbrough@ouhsc.edu

Locations
United States, Oklahoma
Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Osama Qubaiah, MD    405-271-4022    osama-qubaiah@ouhsc.edu   
Contact: Melissa Yarbrough, RN    405-271-8777    melisssa-yarbrough@ouhsc.edu   
Principal Investigator: Osama Qubaiah, MD         
Sponsors and Collaborators
University of Oklahoma
Celgene Corporation
Investigators
Principal Investigator: Osama Qubaiah, MD University of Oklahoma
  More Information

Additional Information:
No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01167816     History of Changes
Other Study ID Numbers: VZ-PANC-PI-0244
Study First Received: July 21, 2010
Last Updated: February 27, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Azacitidine
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 16, 2014