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A Pilot Study of Molecularly Tailored Therapy for Patients With Metastatic Pancreatic Cancer

Phase 2
18 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

A Pilot Study of Molecularly Tailored Therapy for Patients With Metastatic Pancreatic Cancer

Inclusion Criteria:

- Histologically proven pancreatic adenocarcinoma with measurable disease

- Biopsy accessible tumor deposits

- ECOG performance status 0-2

- Age >/= 18 years

- Subjects with no brain metastases or history of previously treated brain metastases

- Adequate hepatic, renal, and bone marrow function

- Partial thromboplastin time must be normal range and INR < 1.5

- Life expectancy > 12 weeks

- Women of childbearing potential must have a negative seum pregnancy test within 14
days prior to initiation of treatment

- Subject is capable of understanding and complying with parameters as outlines in the
protocol and able to sign and date the consents

Exclusion Criteria:

- CNS metastases which do not meet criteria outlines in inclusion criteria

- Active severe infection or known chronic infection with HIV or hepatitis B virus

- Cardiovascular disease

- Life threatening visceral disease or other severe concurrent disease

- Women who are pregnant, breastfeeding, or women of childbearing potential not using
dual forms of effective contraception

- Anticipated patient survival under 3 months

- Patients receiving any other investigational agents

- History of allergic reactions attributed to compounds of similar chemical or
biological composition to gemcitabine, oxaliplatin, 5-FU, docetaxel or irinotecan

- Uncontrolled intercurrent illness

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Timing of biopsy and treatment

Outcome Description:

The number of days from study entry to biopsy to molecular results to first dose

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Michael Pishvaian, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University


United States: Food and Drug Administration

Study ID:




Start Date:

December 2012

Completion Date:

December 2014

Related Keywords:

  • Pancreatic Cancer
  • Pancreas
  • cancer
  • metastatic
  • chemotherapy
  • Pancreatic Neoplasms



Georgetown University- Lombardi Comprehensive Cancer Center Washington, District of Columbia  20007
MedStar Montgomery Medical Center Olney, Maryland  20832