Pancreatic Cancer
Conditions
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.
Interventions
DRUGVidaza
Vidaza will be administered subq daily for 5 consecutive days each 28-day cycle
Sponsors
Celgene Corporation
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine maximum tolerated dose | 28 days | 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 |
| Toxicity | 28 days | To describe the toxicity associated with the use of this combination regimen |
Secondary
| Measure | Time frame | 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. |
Countries
United States
Outcome results
None listed