Preoperative Folfirinox for Resectable Pancreatic Adenocarcinoma - A Phase II Study

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT02345460
Phase
PHASE2
Status
Terminated

Conditions

  • Pancreatic Adenocarcinoma
  • Poorly Differentiated Malignant Neoplasm
  • Resectable Pancreatic Cancer
  • Stage IA Pancreatic Cancer
  • Stage IB Pancreatic Cancer
  • Stage IIA Pancreatic Cancer
  • Stage IIB Pancreatic Cancer
  • Stage III Pancreatic Cancer
  • Undifferentiated Pancreatic Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan Hydrochloride — DRUG
    Given IV
  • Oxaliplatin — DRUG
    Given IV
  • Leucovorin Calcium — DRUG
    Given IV
  • Fluorouracil — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies

Study Details

This phase II trial studies how well combination chemotherapy works in treating patients with pancreatic cancer before undergoing surgery. Drugs used in chemotherapy, such as irinotecan hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil (FOLFIRINOX), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Key Dates

Start date
Sep 30, 2015
Status verified
Jun 2018
Primary completion
Feb 29, 2016
Completion
Mar 31, 2016

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (FOLFIRINOX)
    Patients receive FOLFIRINOX regimen comprising irinotecan hydrochloride IV over 90 minutes, oxaliplatin IV over 120 minutes, leucovorin calcium IV over 120 minutes, and fluorouracil IV over 1-2 minutes and then continuously over 46 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Patients Undergoing Surgical Resection After Receiving at Least 4 of the 6 Courses of Preoperative Chemotherapy [ Time Frame: Up to 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterClevelandOhio44195-

Find similar trials in Cleveland, OH

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center· Cleveland, OH

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