Phase I Trial Of 5-Azacitidine Plus Gemcitabine In Patients With Advanced Pancreatic Cancer

Study Overview

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

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.

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.

Pancreatic Cancer

DRUG: Vidaza

VZ-PANC-PI-0244

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-07-21	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-05-19
First Submitted that Met QC Criteria 2010-07-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-05-20
First Posted (ESTIMATED) 2010-07-22	Results First Posted N/A	Last Verified 2014-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: azacitabine	DRUG: Vidaza Vidaza will be administered subq daily for 5 consecutive days each 28-day cycle

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: azacitabine

DRUG: Vidaza

Vidaza will be administered subq daily for 5 consecutive days each 28-day cycle

Primary Outcome Measures	Measure Description	Time Frame
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	28 days
Toxicity	To describe the toxicity associated with the use of this combination regimen	28 days

Secondary Outcome Measures	Measure Description	Time Frame
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.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Celgene Corporation

Investigators

PRINCIPAL_INVESTIGATOR: Osama Qubaiah, MD, University of Oklahoma

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record