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

Metastatic Pancreatic Cancer Clinical Trial

— 278  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01744353
• Other study ID #: BrUOG 278
• Status: Completed
• Phase: Phase 1
• Start date: November 2012
• Est. completion date: August 2015

Study information

• Verified date: February 2020
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Dose level 1
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
• Dose level 2/MTD
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
• Dose level 3
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

Locations

Country	Name	City	State
United States	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

Sponsors (4)

Lead Sponsor	Collaborator
Brown University	Lifespan, Memorial Hospital of Rhode Island, Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Toxicities to Define MTD of FOLFOX-Abraxane (A) for Newly Diagnosed, Advanced Pancreatic Cancer.	MTD (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) was defined by protocol documented and predefined DLT's in 3 dose levels.	For up to 30 days post completing drug, an expected average of 6 months
Secondary	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.	Data below summarizes number of patients who experienced partial response. Partial response evaluated in this study using the international criteria proposed in the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1 Response Criteria Partial Response (PR) At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters	pre-drug until disease progression, whichever comes first, for an expected average of 6 months