BrUOG 278: FOLFOX-A For Pancreatic Cancer A Brown University Oncology Research Group Study
Condition: Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Dose level 1; Dose level 2/MTD; Dose level 3
Intervention description: Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion; Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion; Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Intervention MeSH terms: Oxaliplatin; Albumin-Bound Paclitaxel; Paclitaxel
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: newly diagnosed; advanced pancreatic cancer; pancreatic cancer; metastatic pancreatic cancer; pancreas

Summary:

      The purpose of this study is to test the safety, activity and best doses of FOLFOX-A which
      consists of the standard chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and
      abraxane. Each of these drugs are currently used in pancreatic cancer.

      The experimental part of the study is combining these drugs together in FOLFOX-A.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed pancreatic ductal adenocarcinoma.

          -  Metastatic or locally advanced disease.

          -  No prior treatment for pancreatic cancer

          -  Radiographically measurable disease.

          -  No major surgery within 4 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.
             Laparoscopy and central venous catheter placement are not considered major surgery.

          -  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

          -  Preexisting neuropathy > grade 1.

          -  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 years of age.

          -  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.

          -  Required Initial Laboratory Values:

               -  Neutrophils ≥ 1,500/μl

               -  Platelet count ≥ 100,000/μl

               -  Creatinine ≤ 1.5 mg/dL -or- creatinine clearance ≥ 60 mL/min

               -  Total bilirubin ≤ 1.5 x ULN

               -  AST (SGOT) & ALT (SGPT) ≤ 3.0 x ULN

        Exclusion Criteria:

        -Patients with known brain metastases