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Trial record 52 of 2865 for:    Pancreatic Cancer

FOLFOX-A For Locally Advanced Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial

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ClinicalTrials.gov Identifier: NCT02578732
Recruitment Status : Recruiting
First Posted : October 19, 2015
Last Update Posted : April 12, 2019
Sponsor:
Collaborators:
Brown University
Rhode Island Hospital
Information provided by (Responsible Party):
howard safran, Brown University

Brief Summary:
Preliminary data suggests that FOLFOX-A may have equal or superior activity as compared to FOLFIRINOX for patients with metastatic pancreatic cancer and appears to be better tolerated with the ability to administer at least 10 cycles of therapy. Investigators therefore will evaluate FOLFOX-A in a phase II study for patient with locally advanced pancreatic cancer.

Condition or disease Intervention/treatment Phase
Locally Advanced Pancreatic Cancer Pancreatic Cancer Drug: FOLFOXA Phase 2

Detailed Description:
See summary above

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BrUOG 318: FOLFOX-A For Locally Advanced Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial
Study Start Date : June 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FOLFOXA

Schema:

1 cycle = 14 days **It will not be considered a deviation if a cycle or pre-cycle assessment must be adjusted to accommodate scheduling or holidays. Adjustment must be documented with reason to BrUOG**

Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.

Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)

  • It is at the discretion of the treating physician to give Neulasta, 6 mg sq x 1 post treatment
  • Antiemetics will be administered as per standard institutional policy.
Drug: FOLFOXA

Schema:

1 cycle = 14 days **It will not be considered a deviation if a cycle or pre-cycle assessment must be adjusted to accommodate scheduling or holidays. Adjustment must be documented with reason to BrUOG**

Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.

Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)

  • It is at the discretion of the treating physician to give Neulasta, 6 mg sq x 1 post treatment
  • Antiemetics will be administered as per standard institutional policy.
Other Name: FOLFOXA is a combination treatment including: Abraxane, Oxaliplatin, Leucovorin




Primary Outcome Measures :
  1. Response rate of FOLFOX-A for patients with locally advanced pancreatic cancer. [ Time Frame: Until progression up to 5 years ]

Secondary Outcome Measures :
  1. Overall survival for patients with locally advanced pancreatic cancer treated with FOLFOX-A [ Time Frame: During treatment (approximately every 2 weeks for up to 6 months), then approximately every 4 months for for a maximum of 5 years ]


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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:

  • Pathologically or cytologically confirmed pancreatic ductal adenocarcinoma. Patients with pathology or cytology showing carcinoma of pancreas or adenosquamous of the pancreas are also eligible.
  • Locally advanced pancreatic cancer, including patients defined by Callery19 as "unresectable" and "borderline resectable" are eligible:
  • Measurable disease as per RECIST 1.1
  • No prior chemotherapy for pancreatic cancer.
  • No major surgery within 3 weeks of the start of study treatment. Patients must have recovered from the side effects of any major surgery at the start of study treatment. For questions on if a surgery is deemed "major," definition by surgeon can be used for clarification. Laparoscopy and central venous catheter placement are not considered major surgery.
  • No prior invasive malignancy within the prior two years. However, patients with an early stage malignancy that is not expected to require treatment in the next 2 years (such as early stage, resected breast cancer or asymptomatic prostate cancer) are eligible.
  • ECOG performance status 0 or 1.
  • Age ≥ 18
  • Not pregnant and not nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to beginning of treatment. Post-menopausal women (surgical menopause or lack of menses >24 months) do not need to have a pregnancy test, please document status.
  • Women of childbearing potential and sexually active males must use an effective contraception method 28 days prior to treatment, during treatment and for three months after completing treatment (men are to use contraception for six months post last dose of drug). Documentation of this being discussed required.
  • Required Initial Laboratory Values:

    • Neutrophils ≥ 1,500/mm3
    • Platelet count ≥ 100,000/mm3 (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to laboratory sample)
    • Hemoglobin > 9.0g/dL
    • Creatinine ≤ 1.5 mg/dL -or- creatinine clearance ≥ 60 mL/min
    • Total bilirubin <1. 5 x ULN
    • AST (SGOT) & ALT (SGPT) ≤ 2.5 x ULN
    • Alkaline phosphatase < 2.5xULN. (Patients with elevated alkaline phosphatase, total bilirubin, AST and ALT, who have subsequently undergone biliary stenting and their liver tests are improving, do not need to wait for their alkaline phosphatase to become < 2.5x ULN if their total bilirubin, AST and ALT have improved to within required study levels and the alkaline phosphatase is decreasing.)

Exclusion Criteria:

  • Patients with metastatic disease
  • Prior hypersensitivity to Oxaliplatin or Abraxane ® that in the investigators opinion would put the patient at risk if re-exposed
  • Preexisting neuropathy is not allowed from any cause.
  • Patients with serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive FOLFOX-A
  • Patients with unstable biliary stents or with plastic stents. Information on type of stent is required at registration.
  • Patients with active infection or fever (patients on antibiotics for infection or patients getting over a cold or seasonal virus are not excluded), or known historical or active infection with HIV, hepatitis B, or hepatitis C.
  • Patients with active sepsis or pneumonitis.
  • Patients with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies that in the investigator's opinion would put the patient at an increased risk.
  • Uncontrolled diabetes. If patient has diabetes, confirmation on status (controlled or uncontrolled) required at registration.

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): NCT02578732


Contacts
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Contact: Helena Lau, MSPH 401-413-3000 helena_lau@brown.edu

Locations
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United States, Rhode Island
Rhode Island Hospital and The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02903/02906
Contact: Helena Lau, MSPH    401-863-3000    helena_lau@brown.edu   
Principal Investigator: Howard Safran, MD         
Sponsors and Collaborators
howard safran
Brown University
Rhode Island Hospital
Investigators
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Principal Investigator: Howard Safran, MD BrUOG

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Responsible Party: howard safran, Principal Investigator, Brown University
ClinicalTrials.gov Identifier: NCT02578732     History of Changes
Other Study ID Numbers: BrUOG 318
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
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
Oxaliplatin
Albumin-Bound Paclitaxel
Paclitaxel
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action