Pancreatic Neoplasms Clinical Trial
Official title:
Phase IB Study of FOLFIRINOX Plus PF-04136309 in Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
This phase I trial studies the side effects and optimal dose of PF-04136309 when given with combination chemotherapy (FOLFIRINOX; 5-fluorouracil, leucovorin, irinotecan, oxaliplatin) in treating patients with locally advanced or borderline resectable pancreatic cancer. These patients are not candidates for surgical resection which is the most effective treatment for pancreatic cancer. Giving PF-04136309 together with FOLFIRINOX may shrink pancreatic tumors in some patients so that surgery becomes an option
PRIMARY OBJECTIVES:
To define the optimal dose and toxicity of PF-04136309 in combination with FOLFIRINOX
(fluorouracil, leucovorin calcium, irinotecan hydrochloride, and oxaliplatin) in patients
with borderline resectable and locally advanced pancreatic cancer.
SECONDARY OBJECTIVES:
- To evaluate the safety of PF-04136309 and FOLFIRINOX by grade 3 or 4 toxicity for
clinical use.
- To determine the tumor control rate (TCR) as defined by stable disease (SD), partial
response (PR), and complete response (CR): TCR = SD + PR + CR.
EXPLORATORY OBJECTIVES:
- To determine the prevalence and function of myeloid-derived suppressor cells (MDSC) in
the bone marrow, peripheral circulation, and tumor before and after treatment with
PF-04136309 and FOLFIRINOX.
- To determine the prevalence and function of MDSC in the bone marrow, peripheral
circulation, and tumor before and after treatment with FOLFIRINOX.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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