Status:
TERMINATED
Phase I Trial of 5-Azacitidine Plus Gemcitabine in Patients With Advanced Pancreatic Cancer
Lead Sponsor:
University of Oklahoma
Collaborating Sponsors:
Celgene Corporation
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ef...
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 inten...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01167816
Start Date
July 1 2010
End Date
January 1 2014
Last Update
May 20 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104