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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01167816
• Other study ID #: VZ-PANC-PI-0244
• Status: Terminated
• Phase: Phase 1
• First received: July 21, 2010
• Last updated: May 19, 2014
• Start date: July 2010
• Est. completion date: January 2014

Study information

• Verified date: May 2014
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Stephenson Cancer Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Toxicity	To describe the toxicity associated with the use of this combination regimen	28 days	Yes
Secondary	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.	unknown	No

External Links

•   OU Cancer Institute
•   OU Cancer Institute