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BrUOG 295: Adjuvant FOLFOX-A For Resected Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial

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ClinicalTrials.gov Identifier: NCT02022033
Recruitment Status : Active, not recruiting
First Posted : December 27, 2013
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
howard safran, Brown University

Brief Summary:
The investigators preliminary data suggests that FOLFOX-A may have equal or superior activity as compared to FOLFIRINOX and appears to be better tolerated. Therefore, FOLFOX-A may be a better regimen in the adjuvant setting for patients with resected pancreatic cancer. This protocol will obtain preliminary data on safety and disease-free and overall survival following administration of FOLFOX-A for patients with resected pancreatic cancer.

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

Detailed Description:
See summary above

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BrUOG 295:Adjuvant FOLFOX-A For Resected Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial
Study Start Date : February 2014
Actual Primary Completion Date : July 23, 2019
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FOLFOXA

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.)

Drug: FOLFOXA

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.)





Primary Outcome Measures :
  1. Toxicity of adjuvant FOLFOX-A [ Time Frame: Prior to beginning drug, each cycle (approximately every 14 days), study completion, and 30 days post last dose of drug, for a total time of approximately 6 months. ]
    CTCAE version 4.0


Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: Three months, six months, after completion of drug (approximately 6 months), and every 3 months until progression (on average up to one year) ]
    RECIST 4.0



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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:

  • Histologic proof of primary pancreas invasive adenocarcinoma or adenosquamous cancer, managed with a potentially curative resection (i.e., removal of all gross tumor). Patients with invasive adenocarcinoma that also contains a component of intraductal papillary mucinous neoplasm (IPMN) are eligible.
  • Interval between definitive tumor-related surgery and registration between 21-70 days.
  • Patients will be staged according to the 6th edition AJCC staging system with pathologic stage T1-3, N0-1, M-0 being eligible.
  • Post resection serum CA19-9 ≤ 180 units/mL within 21 days of registration on study.
  • Preexisting neuropathy < grade 1 (per CTCAE).
  • 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 of lack of menses >12 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 during treatment and for three months after completing treatment.
  • Required Initial Laboratory Values:

    • Neutrophils ≥ 1,500/mm3
    • Platelet count ≥ 100,000/mm3
    • 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 phosphatases < 2.5x ULN
  • Abdominal CT scan with contrast and chest CT/x-ray (CT of chest preferred) within 6 weeks of registration on study. Patients can have PET/MRI of the chest/abdomen instead.

Exclusion Criteria:

  • 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
  • Prior hypersensitivity to Oxaliplatin or Abraxane that in the investigators opinion would put the patient at risk if re-exposed
  • Patients with islet cell (neuroendocrine) tumors, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas.
  • Prior systemic chemotherapy for pancreas cancer; note that prior chemotherapy for a different cancer is allowable. Patients must not have received chemotherapy for a year prior to registering on study
  • 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. This must be documented.

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): NCT02022033


Locations
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United States, Rhode Island
Roxanne Wood
Providence, Rhode Island, United States, 02903
The Miriam Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
howard safran
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: NCT02022033    
Other Study ID Numbers: 295
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by howard safran, Brown University:
Pancreatic Cancer
Adjuvant
Pancreas
Resected
Invasive adenocarcinoma
adenosquamous cancer
Intraductal papillary mucinous neoplasm
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases