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

University of Oklahoma (OU)

Status and phase: Terminated; Phase 1

Conditions: Pancreatic Cancer

Treatments: Drug: Vidaza

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01167816

VZ-PANC-PI-0244

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

9 participants in 1 patient group

azacitabine

Experimental group

Treatment:

Drug: Vidaza