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

Sponsor
University of Oklahoma (Other)
Overall Status
Terminated
CT.gov ID
NCT01167816
Collaborator
Celgene Corporation (Industry)
9
Enrollment
1
Location
1
Arm
42.1
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Trial of 5-Azacitidine Plus Gemcitabine in Patients With Advanced Pancreatic Cancer
Study Start Date :
Jul 1, 2010
Actual Primary Completion Date :
Jan 1, 2014
Actual Study Completion Date :
Jan 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: azacitabine

Drug: Vidaza
Vidaza will be administered subq daily for 5 consecutive days each 28-day cycle
Other Names:
  • Azacitibine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Determine maximum tolerated dose [28 days]

      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

    2. Toxicity [28 days]

      To describe the toxicity associated with the use of this combination regimen

    Secondary Outcome Measures

    1. Determine the effect of azacitidine therapy on DNA methylation in peripheral blood cells []

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Stephenson Cancer Center Oklahoma City Oklahoma United States 73104

    Sponsors and Collaborators

    • University of Oklahoma
    • Celgene Corporation

    Investigators

    • Principal Investigator: Osama Qubaiah, MD, University of Oklahoma

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Oklahoma
    ClinicalTrials.gov Identifier:
    NCT01167816
    Other Study ID Numbers:
    • VZ-PANC-PI-0244
    First Posted:
    Jul 22, 2010
    Last Update Posted:
    May 20, 2014
    Last Verified:
    May 1, 2014
    Additional relevant MeSH terms:
    Pancreatic Neoplasms
    Azacitidine

    Study Results

    No Results Posted as of May 20, 2014