Phase I Trial of 5-Azacitidine Plus Gemcitabine in Patients With Advanced Pancreatic Cancer
This study is currently recruiting participants.
Verified February 2013 by University of Oklahoma
Sponsor:
University of Oklahoma
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01167816
First received: July 21, 2010
Last updated: February 27, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: Vidaza |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Trial of 5-Azacitidine Plus Gemcitabine in Patients With Advanced Pancreatic Cancer |
Resource links provided by NLM:
Further study details as provided by University of Oklahoma:
Primary Outcome Measures:
- Determine maximum tolerated dose [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]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 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]To describe the toxicity associated with the use of this combination regimen
Secondary Outcome Measures:
- Determine the effect of azacitidine therapy on DNA methylation in peripheral blood cells [ Time Frame: unknown ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: azacitabine |
Drug: Vidaza
Vidaza will be administered subq daily for 5 consecutive days each 28-day cycle
Other Name: Azacitibine
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167816
Contacts
| Contact: Osama Qubaiah, MD | 405-271-4022 | osama-qubaiah@ouhsc.edu |
| Contact: Melissa Yarbrough, RN | 405-271-8777 | melissa-yarbrough@ouhsc.edu |
Locations
| United States, Oklahoma | |
| Stephenson Cancer Center | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Osama Qubaiah, MD 405-271-4022 osama-qubaiah@ouhsc.edu | |
| Contact: Melissa Yarbrough, RN 405-271-8777 melisssa-yarbrough@ouhsc.edu | |
| Principal Investigator: Osama Qubaiah, MD | |
Sponsors and Collaborators
University of Oklahoma
Celgene Corporation
Investigators
| Principal Investigator: | Osama Qubaiah, MD | University of Oklahoma |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Oklahoma |
| ClinicalTrials.gov Identifier: | NCT01167816 History of Changes |
| Other Study ID Numbers: | VZ-PANC-PI-0244 |
| Study First Received: | July 21, 2010 |
| Last Updated: | February 27, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Azacitidine Gemcitabine Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 22, 2013