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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine maximum tolerated dose

Outcome Description:

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

Outcome Time Frame:

28 days

Safety Issue:

Yes

Principal Investigator

Osama Qubaiah, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Oklahoma

Authority:

United States: Food and Drug Administration

Study ID:

VZ-PANC-PI-0244

NCT ID:

NCT01167816

Start Date:

July 2010

Completion Date:

July 2014

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms

Name

Location

Stephenson Cancer CenterOklahoma City, Oklahoma  73104