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

NCT01167816 | Terminated Phase 1 DMC

• 1 other identifier: VZ-PANC-PI-0244
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• Toxicity

  To describe the toxicity associated with the use of this combination regimen

  28 days

Secondary Outcomes (1)

• Determine the effect of azacitidine therapy on DNA methylation in peripheral blood cells

Study Arms (1)

azacitabine

EXPERIMENTAL

Drug: Vidaza

Interventions

Vidaza DRUG

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

Also known as: Azacitibine

azacitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Oklahoma: lead
• Celgene Corporation: collaborator

Study Sites (1)

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Osama Qubaiah, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 22, 2010
• Study Start: July 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: May 20, 2014

Record last verified: 2014-05

Locations

US (1)