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

Completed · Phase 1

Conditions studied: Metastatic Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT01744353

Run by

Brown University

People needed

35

Starts

2012-11-01

Expected to finish

2015-08-01

Last updated by the study team

2020-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients with known brain metastases

Where it is running

• Memorial Hospital — Pawtucket, Rhode Island, United States
• Rhode Island Hospital (including Newport and East Greenwich locations) — Providence, Rhode Island, United States
• The Miriam Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.