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Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT02243007
Recruitment Status : Terminated (Slow Accrual)
First Posted : September 17, 2014
Results First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
David Patrick Ryan, MD, Massachusetts General Hospital

Brief Summary:
This research study is a Phase II clinical trial, which evaluates a combination of drugs, FOLFIRINOX and Gemcitabine/Nab-Paclitaxel, in the management of participants with resectable pancreatic cancer prior to surgery.

Condition or disease Intervention/treatment Phase
Resectable Pancreatic Cancer Pancreatic Ductal Carcinoma Drug: FOLFIRINOX Drug: Gemcitabine/nab-Paclitaxel Radiation: Radiation therapy Drug: Capecitabine Phase 2

Detailed Description:

Patients who fulfill eligibility criteria will be randomized to Arm A or Arm B

  • Treatment will be administered on an outpatient basis.
  • Upon registration participants will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
  • After completion of FOLFIRINOX or Gemcitabine/Nab-paclitaxel, all participants without progressive disease will proceed to radiation therapy with capecitabine .
  • Between 2 and 4 weeks after radiation is complete, participants will proceed for surgical resection of pancreatic cancer

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer
Actual Study Start Date : September 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016


Arm Intervention/treatment
Experimental: Folfirinox-ARM A

Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel

  • Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
  • After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
Drug: FOLFIRINOX
Radiation: Radiation therapy
Drug: Capecitabine
Other Name: Xeloda

Experimental: Gemcitabine/nab-Paclitaxel- Arm B
  • Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
  • Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
  • After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
Drug: Gemcitabine/nab-Paclitaxel
Radiation: Radiation therapy
Drug: Capecitabine
Other Name: Xeloda




Primary Outcome Measures :
  1. Survival Rate at 18 Month [ Time Frame: 18 Month ]
    Number of participants surviving after 18 months of study follow-up


Secondary Outcome Measures :
  1. Pathologic Complete Response Rate (pCR). [ Time Frame: 18 Months ]
    Number of patients achieving pathologic complete response at 18 months. Pathologic complete response is defined as the absence of residual invasive disease in the panaceas and in the regional lymph nodes.

  2. Overall Survival Rate [ Time Frame: Baseline, 5 Years ]
    Overall survival rate at five years using Kaplan-Meier survival analysis

  3. Number of Participants With Serious and Non-Serious Adverse Events [ Time Frame: Baseline, 28 Days ]
    Number of Participants with Serious and Non-Serious Adverse Events from baseline to 28 days

  4. Surgical Morbidity Rate [ Time Frame: within 30 days of surgery ]
    Number of patients experiencing a specific surgery related morbidity

  5. 30-day Post-operative Mortality Rate [ Time Frame: 30 Days ]
    Number of patients who died following surgery.

  6. Correlation of Biomarkers With PFS [ Time Frame: 2 Years ]
    Analysis of the correlation between selected bio-markers and progression free survival.

  7. Rate of Pathologic Downstaging [ Time Frame: 2 Years ]
    The number of participants achieving a reduction in the pathological staging of the primary cancer.

  8. Local Control Rate [ Time Frame: 2 Years ]
    The number of participants achieving local control. The local control rate is defined as the number of participants achieving stable disease, partial response, or a complete response.



Information from the National Library of Medicine

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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:

  • Cytologic or histologic proof of pancreatic ductal carcinoma is required prior to study entry.
  • No evidence of metastatic disease as determined by chest CT scan, and abdominal CT scan (or MRI with gadolinium and/or manganese) and laparoscopy. All patients must be staged with a physical exam, chest CT, abdominal CT with intravenous contrast (or abdominal MRI with gadolinium and/or manganese). Only potentially resectable patients are eligible. Potentially resectable is defined as a) no extrapancreatic disease, b) no evidence (on CT) of involvement of the celiac axis or SMA, c) no evidence (CT or MRI) of occlusion of the SMV or SMPV confluence, and d) no evidence of gross peritoneal or distant metastases by laparoscopy.
  • Patients must be 18 years old or older. There will be no upper age restriction.
  • ECOG Performance Status of 0 or 1 are eligible.
  • Life expectancy of greater than 3 months.
  • Lab Values:

    • ANC ≥ 1500 cells/mm3
    • Platelet count at least 100,000 cells/mm3.
    • AST and ALT ≤2.5 x upper limit of normal
    • Total Bilirubin ≤ 5 x upper limit of normal if patient is s/p biliary stenting AND decreasing at least two time points after stenting.
    • Total Bilirubin ≤ 1.5 x upper limit of normal if no biliary stenting was done
    • Serum Creatinine ≤1.5mg/dl OR
    • Creatinine Clearance greater than or equal to 30ml/min (as estimated by Cockroft Gault Equation) (140 - age [yrs]) (body wt [kg])

      • Creatinine clearance for males = ———————————— (72) (serum creatinine [mg/dL])
      • Creatinine clearance for females = 0.85 x male value
  • The effects of radiation on the developing human fetus are known to be teratogenic. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study treatment plus 30 days from the last date of study drug administration. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patients who fulfill any of the following criteria will be excluded:

  • The presence of metastatic disease on imaging or laparoscopy.
  • Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, ongoing infection as manifested by fever.
  • Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test (serum or urine) at baseline. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
  • Any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor.
  • Diagnosis for other invasive carcinomas (except basal cell carcinoma/squamous cell carcinoma of the skin) within the last five years. Carcinoma in-situ is allowed.
  • Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
  • Unwillingness to participate or inability to comply with the protocol for the duration of the study.
  • Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
  • History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance or oral drug intake.
  • Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery.

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): NCT02243007


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: David Ryan, MD Massachusetts General Hospital

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Responsible Party: David Patrick Ryan, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02243007     History of Changes
Other Study ID Numbers: 14-218
First Posted: September 17, 2014    Key Record Dates
Results First Posted: May 16, 2017
Last Update Posted: May 16, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by David Patrick Ryan, MD, Massachusetts General Hospital:
Resectable pancreatic cancer
Pancreatic Ductal Carcinoma
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Carcinoma, Pancreatic Ductal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Neoplasms, Ductal, Lobular, and Medullary
Carcinoma, Ductal
Carcinoma
Digestive System Diseases
Endocrine System Diseases
Adenocarcinoma
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Capecitabine
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