NCT01413022

FOLFIRINOX Plus PF-04136309 in Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma

Phase IB Study of FOLFIRINOX Plus PF-04136309 in Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Pancreatic Neoplasms

Interventions

Type	Name	Description
DRUG	Oxaliplatin
DRUG	Irinotecan
DRUG	Leucovorin
DRUG	Fluorouracil
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	flow cytometry	Correlative studies
OTHER	immunohistochemistry staining method	Correlative studies
OTHER	pharmacological study	Correlative studies
DRUG	PF-04136309

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-10-01
• Completion: 2016-09-01
• First posted: 2011-08-09
• Last updated: 2016-09-19

Locations

1 site across 1 country: United States