Clinical trial NCT01744353: BrUOG 278: FOLFOX-A For Pancreatic Cancer A Brown University Oncology Research Group Study
Official title: BrUOG 278:FOLFOX-A For Pancreatic Cancer :A Brown University Oncology Research Group Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Pancreatic Cancer
Keywords: newly diagnosed
advanced pancreatic cancer
pancreatic cancer
metastatic pancreatic cancer
pancreas
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Lifespan
name: Rhode Island Hospital
name: Memorial Hospital of Rhode Island
First posted: 2012-12-06
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: More active treatments are desperately needed in pancreatic cancer. The regimen of FOLFIRINOX increases survival as compared to gemcitabine but at a cost of increased toxicity. Irinotecan is responsible for much of the toxicity of FOLFIROX but may not contribute significantly to the regimen's activity. Abraxane is a new agent in pancreatic cancer. This albumin-bound nanoparticle form of paclitaxel increases tumor accumulation of paclitaxel though binding of albumin to SPARC in pancreatic cancer stroma. The investigators therefore propose a pilot study of FOLFOX (fluorouracil, leucovorin and oxaliplatin) combined with abraxane to establish the safety and preliminary activity of FOLFOX-A. Patients with inoperable (metastatic and locally advanced) pancreatic cancer will be eligible since the primary outcome is to establish the safety of 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

Primary outcomes:
measure: Assessment of Toxicities to Define MTD of FOLFOX-Abraxane (A) for Newly Diagnosed, Advanced Pancreatic Cancer.
timeFrame: For up to 30 days post completing drug, an expected average of 6 months
Secondary outcomes:
measure: Response Rate (if Patient's Tumor(s)Are Progressing or Being Controlled) Following Treatment With FOLFOX-A for Patients With Newly Diagnosed, Advanced Pancreatic Cancer.
timeFrame: pre-drug until disease progression, whichever comes first, for an expected average of 6 months
Other outcomes:
Locations:
city: Pawtucket
country: United States
facility: Memorial Hospital
state: Rhode Island
city: Providence
country: United States
facility: Rhode Island Hospital (including Newport and East Greenwich locations)
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Brown University
name: Howard Safran, MD
role: PRINCIPAL_INVESTIGATOR
References: