BrUOG 278: FOLFOX-A For Pancreatic Cancer A Brown University Oncology Research Group Study

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brown University
• Collaborators: Lifespan; Memorial Hospital of Rhode Island; Rhode Island Hospital
• Treatments: Albumin-Bound Paclitaxel; Oxaliplatin; Paclitaxel

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