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.

Study Overview

• Status: Terminated
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Vidaza

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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Stephenson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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; Other Names: Azacitibine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	Measure Description
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.

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: Celgene Corporation
• Investigators: Principal Investigator: Osama Qubaiah, MD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: July 21, 2010
• First Submitted That Met QC Criteria: July 21, 2010
• First Posted (Estimate): July 22, 2010

Study Record Updates

• Last Update Posted (Estimate): May 20, 2014
• Last Update Submitted That Met QC Criteria: May 19, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Azacitidine
• Other Study ID Numbers: VZ-PANC-PI-0244