Molecularly Tailored Therapy for Pancreas Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreas, cancer, metastatic, chemotherapy
Eligibility 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 </= 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 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
Sites / Locations
- Georgetown University- Lombardi Comprehensive Cancer Center
- MedStar Montgomery Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Modified FOLFOX-6
Ox-Tax
FOLFIRI
Tax-Iri
Gem-Ox
Gem-5FU
Gem-Tax
Oxaliplatin 85 mg/m2 day 1 and 5-fluorouracil 400 mg/m2 day 1 and Leucovorin 400 mg/m2 day 1 and 5-fluorouracil 2400 mg/m2 over 46 hours on day 1-3 of every 14 day cycle All drugs will be administered until disease progression or unacceptable toxicity are observed
Docetaxel 65 mg/m2 and Oxaliplatin 100 mg/m2 on day 1 every 3 weeks All drugs will be administered until disease progression or unacceptable toxicity are observed
Irinotecan 180 mg/m2 on day 1 and 5-FU 400 mg/m2 on day 1 and Leucovorin 400 mg/m2 day 1 and 5-FU 2400 mg/m2 over 46 hours, days 1-3 as a continuous infusion All drugs will be administered until disease progression or unacceptable toxicity are observed
2 weeks on, 1 week off of Docetaxel 35 mg/m2/week and Irinotecan 50 mg/m2/week Both administered on day 1 of each week of treatment All drugs will be administered until disease progression or unacceptable toxicity are observed
Gemcitabine: 1000 mg/m2 over 100 minutes on Day 1 Oxaliplatin: 100 mg/m2 over 120 minutes on Day 2 of every 14 day cycle All drugs will be administered until disease progression or unacceptable toxicity are observed
Gemcitabine: 1000 mg/m2 over 30 minutes 5-FU 2000/m6 as a 24 hour infusion on days 1, 8, and 15 of every 28 day cycle All drugs will be administered until disease progression or unacceptable toxicity are observed
Gemcitabine 1000 mg/m2 over 30 minutes and Docetaxel 35 mg/m2 over 60 minutes on days 1, 8, and 15 of every 28 day cycle