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Combination Chemotherapy Before and After Surgery in Treating Patients With Localized Pancreatic Cancer

This study is currently recruiting participants.
Verified January 2017 by Yale University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02047474
First Posted: January 28, 2014
Last Update Posted: January 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Yale University
  Purpose
This phase II trial studies how well combination chemotherapy before and after surgery works in treating patients with localized pancreatic cancer. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

Condition Intervention Phase
Acinar Cell Adenocarcinoma of the Pancreas Duct Cell Adenocarcinoma of the Pancreas Stage I Pancreatic Cancer Stage IIA Pancreatic Cancer Stage IIB Pancreatic Cancer Drug: oxaliplatin Drug: leucovorin calcium Drug: irinotecan hydrochloride Drug: fluorouracil Procedure: therapeutic conventional surgery Other: laboratory biomarker analysis Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Peri-Operative Modified Folfirinox in Localized Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Progression free survival rate [ Time Frame: At 12 months ]
    Evaluated using a one-sided 0.10-alpha level exact test. Summarized using Kaplan-Meier curves


Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 5 years ]
    Summarized using Kaplan-Meier curves.

  • Objective response rate [ Time Frame: Up to 5 years ]

Estimated Enrollment: 46
Study Start Date: September 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (mFOLFIRINOX)

NEOADJUVANT THERAPY: Patients receive mFOLFIRINOX comprising oxaliplatin IV over 2 hours, levoleucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV continuously for 46 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

SURGERY: Beginning 3-8 weeks after completion of neoadjuvant therapy patients undergo surgical resection.

ADJUVANT THERARPY: Beginning within 12 weeks after surgery, patients receive mFOLFIRINOX as in neoadjuvant therapy. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: oxaliplatin
Given IV
Other Names:
  • 1-OHP
  • Dacotin
  • Dacplat
  • Eloxatin
  • L-OHP
Drug: leucovorin calcium
Given IV
Other Names:
  • CF
  • CFR
  • LV
Drug: irinotecan hydrochloride
Given IV
Other Names:
  • Campto
  • Camptosar
  • CPT-11
  • irinotecan
  • U-101440E
Drug: fluorouracil
Given IV
Other Names:
  • 5-fluorouracil
  • 5-Fluracil
  • 5-FU
Procedure: therapeutic conventional surgery
Undergo surgical resection
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the progression-free survival in patients with resectable non-metastatic pancreatic cancer treated with peri-operative modified leucovorin calcium, fluorouracil, irinotecan hydrochloride, oxaliplatin (mFOLFIRINOX).

SECONDARY OBJECTIVES:

I. Determine overall survival. II. Determine objective response rate after neoadjuvant mFOLFIRINOX.

TERTIARY OBJECTIVES:

I. Compare R0 resection rate and pathologic stage with institutional historical controls who did not receive neoadjuvant therapy.

II. Correlate early metabolic response, determined by changes in glucose metabolism using positron emission tomography (PET) scanning, with pathologic response, R0 resection, and pathologic stage.

III. Correlate early metabolic response, determined by changes in glucose metabolism using PET scanning, with progression-free and overall survival.

IV. Correlate pre-operative response of CA19-9 with progression-free and overall survival.

V. Collect and bank serial serum and plasma specimens from subjects for future correlative biomarker studies.

VI. Collect and bank tumor tissue from subjects prior to treatment (from the diagnostic endoscopic ultrasonography [EUS]-guided biopsy) and after treatment with six cycles of FOLFIRINOX (from the surgical specimen) for future correlative biomarker studies.

OUTLINE:

NEOADJUVANT THERAPY: Patients receive mFOLFIRINOX comprising oxaliplatin intravenously (IV) over 2 hours, levoleucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV continuously for 46 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

SURGERY: Beginning 3-8 weeks after completion of neoadjuvant therapy patients undergo surgical resection.

ADJUVANT THERARPY: Beginning within 12 weeks after surgery, patients receive mFOLFIRINOX as in neoadjuvant therapy. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 2 months for 3 years, every 6 months for 2 years, and then annually thereafter.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologic or cytologic documentation of pancreatic adenocarcinoma
  • Resectable pancreatic adenocarcinoma disease as defined as follows:

    • No evidence of extrapancreatic disease by cross sectional imaging, PET scan, or laparoscopy, including nodal involvement beyond the peripancreatic tissues and/or distant metastases;
    • No evidence of tumor extension to superior mesenteric artery, hepatic artery, celiac axis, aorta, or inferior vena cava, and no evidence of occlusion or encasement of the superior mesenteric vein or superior mesenteric vein/portal vein confluence, as assessed by computed tomography (CT) using pancreatic protocol (or magnetic resonance imaging [MRI] in patients who cannot undergo CT) and EUS
  • No prior treatment (chemotherapy, biological therapy, or radiotherapy) for resectable pancreatic cancer
  • No prior treatment with oxaliplatin, irinotecan (irinotecan hydrochloride), fluorouracil or capecitabine
  • Patients who received chemotherapy > 5 years ago for malignancies other than pancreatic cancer are eligible
  • There is no evidence of the second malignancy at the time of study entry
  • > 4 weeks since major surgery
  • No other concurrent anticancer therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0-1
  • No other malignancy within past five years except basal cell carcinoma of the skin, cervical carcinoma in situ, or non-metastatic prostate cancer
  • Paraffin block or slides must be available
  • Adequate organ function
  • No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
  • No >= grade 2 sensory peripheral neuropathy
  • No uncontrolled seizure disorder, active neurological disease, or known central nervous system (CNS) disease
  • No significant cardiac disease, including the following: unstable angina, New York Heart Association class II-IV congestive heart failure, myocardial infarction within six months prior to study enrollment
  • No history of chronic diarrhea
  • Not pregnant and not nursing
  • No other medical condition or reason that, in the opinion of the investigator, would preclude study participation
  • Absolute neutrophil count >= 1,500/uL
  • Platelet count >= 100,000/uL
  • Hemoglobin >= 9 g/dL
  • Creatinine < 1.5 X upper limit of normal (ULN) or
  • Estimated glomerular filtration rate (GFR) > 30 ml/min
  • Bilirubin =< 1.5 X ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 X ULN
  • Negative pregnancy test in women of childbearing age
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02047474


Contacts
Contact: Kamil Sadowski, BS, CCRC 203-785-6661 kamil.sadowski@yale.edu

Locations
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520-8032
Contact: Kamil Sadowski    203-785-6661    kamil.sadowski@yale.edu   
Principal Investigator: Jill Lacy         
Sponsors and Collaborators
Yale University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jill Lacy Yale University
  More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02047474     History of Changes
Other Study ID Numbers: 1306012255
NCI-2013-02349 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
1306012255 ( Other Identifier: Yale University )
P30CA016359 ( U.S. NIH Grant/Contract )
First Submitted: January 24, 2014
First Posted: January 28, 2014
Last Update Posted: January 20, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Pancreatic Neoplasms
Adenocarcinoma
Carcinoma, Acinar Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Oxaliplatin
Irinotecan
Camptothecin
Fluorouracil
Levoleucovorin
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes