- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02047474
Combination Chemotherapy Before and After Surgery in Treating Patients With Localized Pancreatic Cancer
Phase II Study of Peri-Operative Modified Folfirinox in Localized Pancreatic Cancer
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Connecticut
-
Fairfield, Connecticut, United States, 06824
- Smilow Cancer Hospital at Fairfield
-
Guilford, Connecticut, United States, 06437
- Smilow Cancer Hospital at Guilford
-
Hartford, Connecticut, United States, 06105
- Smilow Cancer Hospital at St. Francis Hospital
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New Haven, Connecticut, United States, 06520-8032
- Yale University
-
North Haven, Connecticut, United States, 06473
- Smilow Cancer Hospital at North Haven
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Orange, Connecticut, United States, 06477
- Smilow Cancer Hospital at Orange
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Torrington, Connecticut, United States, 06790
- Smilow Cancer Hospital at Torrington
-
Trumbull, Connecticut, United States, 06611
- Smilow Cancer Hospital at Trumbull
-
Waterbury, Connecticut, United States, 06708
- Smilow Cancer Hospital at Waterbury
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
Correlative studies
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Undergo surgical resection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: Up to 5 years
|
Summarized using Kaplan-Meier curves.
|
Up to 5 years
|
Objective response rate
Time Frame: Up to 5 years
|
Up to 5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Adenocarcinoma
- Pancreatic Neoplasms
- Carcinoma, Acinar Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Topoisomerase Inhibitors
- Micronutrients
- Vitamins
- Calcium-Regulating Hormones and Agents
- Topoisomerase I Inhibitors
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Oxaliplatin
- Leucovorin
- Irinotecan
- Calcium
- Levoleucovorin
Other Study ID Numbers
- 1306012255 (OTHER: Yale University)
- P30CA016359 (U.S. NIH Grant/Contract)
- NCI-2013-02349 (REGISTRY: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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