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

NCT ID: NCT01167816

Last Updated: 2014-05-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2014-01-31

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

azacitabine

Group Type: EXPERIMENTAL

Vidaza

Intervention Type: DRUG

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

Interventions

Vidaza

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

Intervention Type: DRUG

Other Intervention Names

Azacitibine

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Osama Qubaiah, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

VZ-PANC-PI-0244

Identifier Type: -

Identifier Source: org_study_id