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Trial record 30 of 2862 for:    Pancreatic Cancer

BrUOG 292: FOLFOX-A For Metastatic Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial

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ClinicalTrials.gov Identifier: NCT02080221
Recruitment Status : Recruiting
First Posted : March 6, 2014
Last Update Posted : April 12, 2019
Sponsor:
Collaborators:
Brown University
Lifespan
SouthCoast Medical Group
Memorial hospital
Information provided by (Responsible Party):
howard safran, Brown University

Brief Summary:
A standard treatment for your cancer is called FOLFIRINOX (this utilizes the FDA approved chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and irinotecan). In this study you will receive the chemotherapy treatment FOLFOX-A (fluorouracil, oxaliplatin, leucovorin and Abraxane ®) which substitutes irinotecan for the FDA approved chemotherapy drug Abraxane ®. Even though Abraxane is FDA approved for pancreatic cancer, the combination of Abraxane with the other 3 drugs is being investigated. Your doctors are studying the activity and side effects of FOLFOX-A in advanced (metastatic) pancreatic cancer.

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

Detailed Description:
See summary above

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BrUOG 292: FOLFOX-A For Metastatic Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial
Study Start Date : August 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FOLFOXA

1 cycle = 14 days 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
Other Names:
  • 1 cycle = 14 days
  • 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. Survival for patients with metastatic pancreatic cancer with first-line treatment with FOLFOX-A as compared to historical controls of gemcitabine alone. [ Time Frame: Every 3 months for up to 5 years ]

Secondary Outcome Measures :
  1. Toxicities associated with FOLFOX-A for metastatic pancreatic cancer [ Time Frame: Prior to each cycle of treatment then up to 30 days post the last dose of drug, on average for 6 months ]


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:

  1. Pathologically or cytological confirmed pancreatic ductal adenocarcinoma. Patients with pathology or cytology showing carcinoma of pancreas or adenosquamous of the pancreas are also eligible.
  2. Metastatic advanced disease.
  3. No prior chemotherapy for pancreatic cancer
  4. 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.
  5. 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.
  6. ECOG performance status 0 or 1.
  7. Age ≥ 18
  8. 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 >12 months) do not need to have a pregnancy test, please document status.
  9. Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment. Documentation of this being discussed required.
  10. 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 ≤ 1.25 x ULN
    • AST (SGOT) & ALT (SGPT) ≤ 2.5 x ULN (for patients with liver metastases, AST&ALT < 5xULN)
    • Alkaline phosphatase < 2.5xULN, unless bone metastasis is present and in the absence of liver metastasis

Exclusion Criteria:

  1. Patients with known brain metastases
  2. Prior hypersensitivity to Oxaliplatin or Abraxane ® that in the investigators opinion would put the patient at risk if re-exposed
  3. Preexisting neuropathy
  4. 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 5. Patients with unstable biliary stents or with plastic stents. Information on type of stent is required at registration.

6. 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.

7. Patients with sepsis or pneumonitis. 8. 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.

10. 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): NCT02080221


Contacts
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Contact: Helena U Lau, MD 401-863-3000 helena_lau@brown.edu

Locations
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United States, Massachusetts
Southcoast centers for cancer care Recruiting
Fairhaven, Massachusetts, United States, 02179
Contact: Helena Lau, MSPH    401-863-3000    helena_lau@brown.edu   
Principal Investigator: Elizabeth Blanchard, MD         
United States, Rhode Island
Memorial Hospital of Rhode Island Withdrawn
Pawtucket, Rhode Island, United States, 02860
Lifespan Hospitals (The Miriam and RI Hospital, East Greenwich, Newport) Recruiting
Providence, Rhode Island, United States, 02903
Contact: Helena Lau, MSPH    401-863-3000    helena_lau@brown.edu   
Principal Investigator: Howard Safran, MD         
Sub-Investigator: Kevin Charpentier, MD         
Sponsors and Collaborators
howard safran
Brown University
Lifespan
SouthCoast Medical Group
Memorial 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: NCT02080221     History of Changes
Other Study ID Numbers: BrUOG 292
First Posted: March 6, 2014    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Keywords provided by howard safran, Brown University:
metastatic pancreatic cancer
pancreatic cancer
metastatic
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
Antineoplastic Agents