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Phase II Neoadjuvant Chemotheraphy (Gemcitabine and Nab-Paclitaxel vs. mFOLFIRINOX) and Sterotatic Body Radiation Therapy for Borderline Resectable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT02241551
Recruitment Status : Terminated (Study was terminated with the IRB ended early as logistical concerns of the SBRT)
First Posted : September 16, 2014
Results First Posted : June 15, 2018
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Nathan Bahary, MD, University of Pittsburgh

Brief Summary:
This is a prospective, randomized phase II trial. Patients diagnosed with borderline resectable pancreatic adenocarcinoma will be randomly assigned to one of two treatment arms, either mFOLFIRINOX or gemcitabine and nab-paclitaxel. After three cycles of treatment in the gemcitabine/nab-paclitaxel arm and 6 cycles in the mFOLFIRINOX arm, patients will be restaged with CT scans and if they remain borderline resectable or have improvement of their disease They will then proceed to SBRT followed by surgical resection.

Condition or disease Intervention/treatment Phase
Borderline Resectable Pancreatic Cancer Drug: gemcitabine/nab-paclitaxel Drug: mFOLFIRINOX Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Neoadjuvant Chemotheraphy (Gemcitabine and Nab-Paclitaxel vs. mFOLFIRINOX) and Sterotatic Body Radiation Therapy for Borderline Resectable Pancreatic Cancer
Study Start Date : December 2014
Actual Primary Completion Date : March 3, 2017
Actual Study Completion Date : March 3, 2017


Arm Intervention/treatment
Experimental: gemcitabine/nab-paclitaxel
three cycles of treatment in the gemcitabine/nab-paclitaxel
Drug: gemcitabine/nab-paclitaxel
three cycles of treatment in the gemcitabine/nab-paclitaxel
Other Names:
  • Gemzar
  • ABRAXANE

Experimental: mFOLFIRINOX
6 cycles in the mFOLFIRINOX
Drug: mFOLFIRINOX
6 cycles in the mFOLFIRINOX
Other Names:
  • irinotecan
  • fluorouracil
  • oxaliplatin




Primary Outcome Measures :
  1. Safety and Efficacy Using Neo-adjuvant Gemcitabine Plus Nab-paclitaxel in Patients Receiving SBRT and Surgery for Borderline Resectable Pancreatic Cancer, Using Neo-adjuvant mFOLFIRINOX as a Control [ Time Frame: up to 5 years ]
    Efficacy: pathological complete response (pCR) and R0 resection. Safety: Grade 4 toxicity.


Secondary Outcome Measures :
  1. R0 Resection Rates in Borderline Resectable Pancreatic Cancer [ Time Frame: Up to 5 years ]
  2. Incidence of Grade 3 and 4 Toxicities for the 2 Chemotherapy Regimens That Occur After Cycle 1 Day 1 [ Time Frame: Up to 5 years ]
    According to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTAE, v4.0)

  3. Ca19-9 Response to Neoadjuvant Chemotherapy [ Time Frame: Up to 5 years ]
  4. Time to Disease Progression [ Time Frame: Up to 5 years ]
  5. Measurement of Biomarkers (SPARC, RM1 and SMAD4) in Tissues [ Time Frame: Up to 5 years ]
    This wil be measured in tissues that are obtained at screening and in the resected tumour specimen

  6. Radiological Response Rate to Therapy [ Time Frame: Up to 5 years ]
    Radiological improvements will be evaluated by determining changes in density of measurable disease on CT scan pre and post chemotherapy

  7. Quality of Life Effects of Chemotherapy on Patients Receiving Chemotherapy and SBRT [ Time Frame: Up to 5 years ]
    This will be measured using the FACT-HB questionaire



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

Inclusion Criteria:

All patients must meet the following criteria within 28 days of randomization (unless otherwise indicated) to be enrolled in the protocol:

  • Histologically or cytologically proven adenocarcinoma of the pancreas. If the patient has mixed tumor with predominant adenocarcinoma pathology, they can be enrolled.
  • Subjects will be staged according to the 2010 American Joint Committee on Cancer (AJCC) staging system with pathologic stage T1-4, N0 being eligible; and have a primary tumor of the pancreas (either pancreatic head, neck, uncinate process, or body/tail)
  • The tumor must be deemed as being borderline resectable. Final CT confirmation of surgical staging/ eligibility will be at the discretion of the pancreatic surgeon of the patient.
  • Disease is confined to locoregional site as confirmed by the CT and / or diagnostic staging laparoscopy to avoid occult peritoneal deposits. Diagnostic laproscopy will be only if absolutely required
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) on imaging studies CT
  • Screening Endoscopic ultrasound if done prior to consent but within 6 weeks of expected randomization date it may be used.
  • Karnofsky performance status greater than or equal to 70 or Eastern Cooperative Oncology Group (ECOG) performance of 0-2.
  • Age > 18
  • Estimated life expectance > 12 weeks
  • If female patient is of child bearing potential, she must have a negative serum pregnancy test (βhCG) documented up to 72hrs prior to administration of first study drug
  • Patient has screening blood work performed which includes the following (should be drawn ≤ 14 days prior to randomization)
  • absolute neutrophil count (ANC) > 1.5 x 109/L
  • Platelet count ≥ 100000/mm3
  • Hemoglobin (HgB) ≥ 9g/dL
  • aspartate aminotransferase (AST),Alanine Aminotransferase (ALT)≤ 2.5 x upper limit of normal (ULN) Total Bilirubin ≤ ULN
  • Serum Cr within normal limits (WNL)
  • Coagulation studies with Prothrombin Time and International Normalized Ratio (PT/INR) and partial thromboplastin time (PTT) within normal limits (±15%). • Patient has a urinalysis obtained (≤14 days prior to randomization) and the results are deemed not clinically significant by the investigator.
  • Patient has no evidence of jaundice at the time of enrolment. If stent is required to alleviate jaundice, it should be metallic. If patient has a previously placed stent and this is plastic, this should be changed to metallic.
  • Patient's pain symptoms have remained stable with no adjustment to analgesics within 7 days prior to randomization. Patient must be able to swallow entreat medications with no requirement for a feeding tube. Patient's must not have intractable nausea or vomiting which prohibits the patient from oral medications
  • Diabetes must be controlled prior to enrollment
  • Disease must be encompassed in a reasonable SBRT "portal" as defined by the treating radiation oncologist

Exclusion Criteria:

  • Ineligible Histology including non-adenocarcinomas, adenosquamous carcinoma, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct and ampullary carcinomas
  • Evidence of distant metastasis on upright chest x-ray, CT or other staging studies
  • Subjects with recurrent disease
  • Prior radiation therapy to the upper abdomen or liver at the discretion of the treating radiation oncologist could impair delivery of the prescribed radiation treatment
  • Prior chemotherapy
  • Subjects in their reproductive age who are breast feeding or have a positive pregnancy test
  • Any co-morbid condition of sufficient severity to limit full compliance with the protocol per assessment by the individual treating physician
  • Concurrent active infection
  • Previous or current malignancies of other histologies within the last 3 yrs prior to randomization; with the exception of cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low risk prostate cancer
  • Patient with known historical or active infection with HIV, Hepatitis B or Hepatitis C
  • Patient who has undergone recent major surgery, other than diagnostic surgical procedure within 4 weeks prior to randomization.
  • Patient who has a history of allergy or hypersensitivity to any of the study drugs.
  • Patients with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, interstitial pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
  • Patients with greater than 2 screening peripheral neuropathy.

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): NCT02241551


Locations
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United States, Pennsylvania
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Nathan Bahary, MD
  Study Documents (Full-Text)

Documents provided by Nathan Bahary, MD, University of Pittsburgh:

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Responsible Party: Nathan Bahary, MD, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02241551     History of Changes
Other Study ID Numbers: UPCI 13-143
First Posted: September 16, 2014    Key Record Dates
Results First Posted: June 15, 2018
Last Update Posted: July 25, 2018
Last Verified: June 2018
Keywords provided by Nathan Bahary, MD, University of Pittsburgh:
Borderline
Resectable
Pancreatic
Cancer
Neoadjuvant
Chemotheraphy
Gemcitabine
Nab-Paclitaxel
mFOFIRINOX
Sterotatic Body Radiation Therapy
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs