Overview

Molecularly Tailored Therapy for Pancreas Cancer

Status:
Completed
Trial end date:
2018-01-24
Target enrollment:
0
Participant gender:
All
Summary
Patient therapy is tailored according to the molecular profile of the patient's tumor.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Georgetown University
Treatments:
Camptothecin
Docetaxel
Fluorouracil
Gemcitabine
Irinotecan
Leucovorin
Levoleucovorin
Oxaliplatin
Criteria
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