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

Primary Purpose

Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Stage I Pancreatic Cancer

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
oxaliplatin
leucovorin calcium
irinotecan hydrochloride
fluorouracil
therapeutic conventional surgery
laboratory biomarker analysis
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acinar Cell Adenocarcinoma of the Pancreas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Smilow Cancer Hospital at Fairfield
  • Smilow Cancer Hospital at Guilford
  • Smilow Cancer Hospital at St. Francis Hospital
  • Yale University
  • Smilow Cancer Hospital at North Haven
  • Smilow Cancer Hospital at Orange
  • Smilow Cancer Hospital at Torrington
  • Smilow Cancer Hospital at Trumbull
  • Smilow Cancer Hospital at Waterbury

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (mFOLFIRINOX)

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression free survival rate
Evaluated using a one-sided 0.10-alpha level exact test. Summarized using Kaplan-Meier curves

Secondary Outcome Measures

Overall survival
Summarized using Kaplan-Meier curves.
Objective response rate

Full Information

First Posted
January 24, 2014
Last Updated
October 31, 2022
Sponsor
Yale University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02047474
Brief Title
Combination Chemotherapy Before and After Surgery in Treating Patients With Localized Pancreatic Cancer
Official Title
Phase II Study of Peri-Operative Modified Folfirinox in Localized Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 25, 2014 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Stage I Pancreatic Cancer, Stage IIA Pancreatic Cancer, Stage IIB Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (mFOLFIRINOX)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Other Intervention Name(s)
1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Other Intervention Name(s)
CF, CFR, LV
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Other Intervention Name(s)
Campto, Camptosar, CPT-11, irinotecan, U-101440E
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Other Intervention Name(s)
5-fluorouracil, 5-Fluracil, 5-FU
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Description
Undergo surgical resection
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Progression free survival rate
Description
Evaluated using a one-sided 0.10-alpha level exact test. Summarized using Kaplan-Meier curves
Time Frame
At 12 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
Summarized using Kaplan-Meier curves.
Time Frame
Up to 5 years
Title
Objective response rate
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Lacy, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Smilow Cancer Hospital at Fairfield
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Smilow Cancer Hospital at Guilford
City
Guilford
State/Province
Connecticut
ZIP/Postal Code
06437
Country
United States
Facility Name
Smilow Cancer Hospital at St. Francis Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8032
Country
United States
Facility Name
Smilow Cancer Hospital at North Haven
City
North Haven
State/Province
Connecticut
ZIP/Postal Code
06473
Country
United States
Facility Name
Smilow Cancer Hospital at Orange
City
Orange
State/Province
Connecticut
ZIP/Postal Code
06477
Country
United States
Facility Name
Smilow Cancer Hospital at Torrington
City
Torrington
State/Province
Connecticut
ZIP/Postal Code
06790
Country
United States
Facility Name
Smilow Cancer Hospital at Trumbull
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Smilow Cancer Hospital at Waterbury
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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