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

Primary Purpose

Pancreatic Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vidaza
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stephenson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

azacitabine

Arm Description

Outcomes

Primary Outcome Measures

Determine maximum tolerated dose
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
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
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.

Full Information

First Posted
July 21, 2010
Last Updated
May 19, 2014
Sponsor
University of Oklahoma
Collaborators
Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01167816
Brief Title
Phase I Trial of 5-Azacitidine Plus Gemcitabine in Patients With Advanced Pancreatic Cancer
Official Title
Phase I Trial of 5-Azacitidine Plus Gemcitabine in Patients With Advanced Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated as the Prinicipal Investigator left the site- all previous subjects enrolled are deceased
Study Start Date
July 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
Celgene Corporation

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
azacitabine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Vidaza
Other Intervention Name(s)
Azacitibine
Intervention Description
Vidaza will be administered subq daily for 5 consecutive days each 28-day cycle
Primary Outcome Measure Information:
Title
Determine maximum tolerated dose
Description
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
Time Frame
28 days
Title
Toxicity
Description
To describe the toxicity associated with the use of this combination regimen
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Determine the effect of azacitidine therapy on DNA methylation in peripheral blood cells
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osama Qubaiah, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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