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

NCT ID: NCT01744353

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2015-08-31

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.

Conditions

Metastatic Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose level 1

Abraxane 125 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion

Group Type: EXPERIMENTAL

Dose level 1

Intervention Type: DRUG

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 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion

Group Type: EXPERIMENTAL

Dose level 2/MTD

Intervention Type: DRUG

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 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion

Group Type: EXPERIMENTAL

Dose level 3

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

5-FU infusion, leuocovorin, oxaliplatin, Abraxane; 5-FU infusion, leuocovorin, oxaliplatin, Abraxane; 5-FU infusion, leuocovorin, oxaliplatin, Abraxane

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lifespan

OTHER

Sponsor Role: collaborator

Rhode Island Hospital

OTHER

Sponsor Role: collaborator

Memorial Hospital of Rhode Island

OTHER

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

howard safran

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Howard Safran, MD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

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

Countries

United States

Other Identifiers

BrUOG 278

Identifier Type: -

Identifier Source: org_study_id