Status:
COMPLETED
Molecularly Tailored Therapy for Pancreas Cancer
Lead Sponsor:
Georgetown University
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Patient therapy is tailored according to the molecular profile of the patient's tumor.
Detailed Description
This study is for patients with metastatic pancreatic cancer (cancer that has spread to other parts of the body). The purpose of this study is to determine whether molecularly tailored therapy can imp...
Eligibility Criteria
Inclusion
- 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 \</= 1.5 x upper normal limit of institution's 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
- 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
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2018
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01888978
Start Date
December 1 2012
End Date
January 24 2018
Last Update
April 9 2018
Active Locations (2)
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1
Georgetown University- Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007
2
MedStar Montgomery Medical Center
Olney, Maryland, United States, 20832