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

Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:August 2014
End Date:December 2019
Contact:Howard U Safran, MD

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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.

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

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

10. Uncontrolled diabetes. If patient has diabetes, confirmation on status (controlled or
uncontrolled) required at registration.
We found this trial at
Providence, Rhode Island 02903
Principal Investigator: Howard Safran, MD
Phone: 401-863-3000
Providence, RI
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Fairhaven, Massachusetts 02719
Principal Investigator: Elizabeth Blanchard, MD
Phone: 401-863-3000
Fairhaven, MA
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111 Brewster St
Pawtucket, Rhode Island 02860
(401) 729-2000
Memorial Hospital of Rhode Island Memorial Hospital of Rhode Island is a 294-bed community teaching...
Pawtucket, RI
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