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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Metastatic Pancreatic Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity of FOLFOX-Abraxane (A) for patients with newly diagnosed, advanced pancreatic cancer.

Outcome Time Frame:

For up to 30 days post completing drug, an expected average of 6 months

Safety Issue:

Yes

Principal Investigator

Howard Safran, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brown University

Authority:

United States: Food and Drug Administration

Study ID:

BrUOG 278

NCT ID:

NCT01744353

Start Date:

November 2012

Completion Date:

November 2013

Related Keywords:

  • Metastatic Pancreatic Cancer
  • newly diagnosed
  • advanced pancreatic cancer
  • pancreatic cancer
  • metastatic pancreatic cancer
  • pancreas
  • Pancreatic Neoplasms

Name

Location

Rhode Island HospitalProvidence, Rhode Island  02903
The Miriam HospitalProvidence, Rhode Island  02903
Memorial HospitalPawtucket, Rhode Island  02860