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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT01413022
Phase
PHASE1
Status
Completed

Conditions

  • Pancreatic Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Apr 30, 2012
Status verified
Sep 2016
Primary completion
Oct 31, 2013
Completion
Sep 30, 2016

Study Design

Enrollment
44 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Experimental: 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.

Primary Outcome Measure

Optimal dose and dose-limiting toxicity of PF-04136309 in combination with FOLFIRINOX [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

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By research site
Washington University School of Medicine· St Louis, MO

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