FOLFIRINOX Plus PF-04136309 in Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
NCT ID: NCT01413022
Last Updated: 2016-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
44 participants
INTERVENTIONAL
2012-04-30
2016-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A (FOLFIRINOX chemotherapy)
Patients receive FOLFIRINOX chemotherapy comprising of:
* oxaliplatin 85 mg/m2 IV on Day 1
* irinotecan 180 mg/m2 IV on Day 1
* leucovorin 400 mg/m2 IV on Day 1
* 5FU 400 mg/m2 bolus and 2400 mg/m2 CIVI over 46 hours beginning on Day 1
Treatment is repeated every 14 days for 6 cycles.
Oxaliplatin
Irinotecan
Leucovorin
Fluorouracil
laboratory biomarker analysis
Correlative studies
flow cytometry
Correlative studies
immunohistochemistry staining method
Correlative studies
pharmacological study
Correlative studies
Group B (FOLFIRINOX and PF-04136309)
Patients receive FOLFIRINOX chemotherapy comprising of:
* oxaliplatin 85 mg/m2 IV on Day 1
* irinotecan 180 mg/m2 IV on Day 1
* leucovorin 400 mg/m2 IV on Day 1
* 5FU 400 mg/m2 bolus and 2400 mg/m2 CIVI over 46 hours beginning on Day 1
* PF-04136309 500 mg PO BID on days 1-14
Treatment is repeated every 14 days for 6 cycles.
Oxaliplatin
Irinotecan
Leucovorin
Fluorouracil
laboratory biomarker analysis
Correlative studies
flow cytometry
Correlative studies
immunohistochemistry staining method
Correlative studies
pharmacological study
Correlative studies
PF-04136309
Interventions
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Oxaliplatin
Irinotecan
Leucovorin
Fluorouracil
laboratory biomarker analysis
Correlative studies
flow cytometry
Correlative studies
immunohistochemistry staining method
Correlative studies
pharmacological study
Correlative studies
PF-04136309
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient must have radiographically measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 10 mm with computed tomography (CT) scan or magnetic resonance imaging (MRI) or \>= 10 mm with calipers by clinical exam
* Patient myst be \>= 18 years of age.
* Patient must have life expectancy of \> 6 months
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
* Patient must have normal bone marrow and organ function as defined below:
* Absolute neutrophil count \>= 1,500/mcl
* Platelets \>= 100,000/mcl
* Hemoglobin \>= 9.0 g/dL
* Creatinine should be below the upper limit of normal OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal limits
* Patient not on anticoagulation must have International Normalized Ratio (INR) and activated partial thromboplastin time (PTT) \< 1.5 x ULN
* Patients who have had a stent placed for biliary obstruction can be included in the study
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately
* Patient must be able to understand and willing to sign an institutional review board (IRB) approved written informed consent document
Exclusion Criteria
* Patient must not have a history of other malignancy =\< 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix
* Patient must not have received any chemotherapy or radiation for pancreatic cancer
* Patient must not be receiving any other investigational agents
* Patient must not have brain metastases; such patients must be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
* Patient must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to PF-04136309, 5FU (fluorouracil), oxaliplatin, or irinotecan
* Patient must not be on any CYP3A4 inhibitors or inducers as they may have interaction with PF-04136309 and/or irinotecan
* Patient must not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, any clinically active malabsorption syndrome, inflammatory bowel disease, any condition that increases the risk of severe irinotecan gastrointestinal toxicity, or psychiatric illness/social situations that would limit compliance with study requirements
* Patient must not be pregnant and/or breastfeeding
* Patient must not be known to be human immunodeficiency virus (HIV)-positive on combination antiretroviral therapy
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Andrea Wang-Gillam, M.D., PhD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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References
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Nywening TM, Wang-Gillam A, Sanford DE, Belt BA, Panni RZ, Cusworth BM, Toriola AT, Nieman RK, Worley LA, Yano M, Fowler KJ, Lockhart AC, Suresh R, Tan BR, Lim KH, Fields RC, Strasberg SM, Hawkins WG, DeNardo DG, Goedegebuure SP, Linehan DC. Targeting tumour-associated macrophages with CCR2 inhibition in combination with FOLFIRINOX in patients with borderline resectable and locally advanced pancreatic cancer: a single-centre, open-label, dose-finding, non-randomised, phase 1b trial. Lancet Oncol. 2016 May;17(5):651-62. doi: 10.1016/S1470-2045(16)00078-4. Epub 2016 Apr 4.
Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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NCI-2011-01154
Identifier Type: REGISTRY
Identifier Source: secondary_id
201201124
Identifier Type: -
Identifier Source: org_study_id
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