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

• ClinicalTrials.gov Identifier: NCT01744353
• Recruitment Status: Completed
• First Posted: December 6, 2012
• Results First Posted: April 11, 2016
• Last Update Posted: April 24, 2019
• Sponsor: Brown University
• Collaborators: Lifespan; Rhode Island Hospital; Memorial Hospital of Rhode Island
• Information provided by (Responsible Party): howard safran, Brown University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Metastatic Pancreatic Cancer	Drug: Dose level 1; Drug: Dose level 2/MTD; Drug: Dose level 3	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: BrUOG 278:FOLFOX-A For Pancreatic Cancer :A Brown University Oncology Research Group Study
• Study Start Date: November 2012
• Actual Primary Completion Date: September 2014
• Actual Study Completion Date: August 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	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; Other Name: 5-FU infusion, leuocovorin, oxaliplatin, Abraxane
Experimental: 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	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; Other Name: 5-FU infusion, leuocovorin, oxaliplatin, Abraxane
Experimental: 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	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; Other Name: 5-FU infusion, leuocovorin, oxaliplatin, Abraxane

Outcome Measures

Primary Outcome Measures :

1. Assessment of Toxicities to Define MTD of FOLFOX-Abraxane (A) for Newly Diagnosed, Advanced Pancreatic Cancer. [ Time Frame: For up to 30 days post completing drug, an expected average of 6 months ]
   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.

Secondary Outcome Measures :

1. 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. [ Time Frame: pre-drug until disease progression, whichever comes first, for an expected average of 6 months ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Rhode Island

Memorial Hospital

Pawtucket, Rhode Island, United States, 02860

Rhode Island Hospital (including Newport and East Greenwich locations)

Providence, Rhode Island, United States, 02903

The Miriam Hospital

Providence, Rhode Island, United States, 02906

Sponsors and Collaborators

Brown University

Lifespan

Rhode Island Hospital

Memorial Hospital of Rhode Island

Investigators

• Principal Investigator: Howard Safran, MD; Brown University

More Information

• Responsible Party: howard safran, Principal Investigator, Brown University
• ClinicalTrials.gov Identifier: NCT01744353 History of Changes
• Other Study ID Numbers: BrUOG 278
• First Posted: December 6, 2012
• Results First Posted: April 11, 2016
• Last Update Posted: April 24, 2019
• Last Verified: April 2019

Keywords provided by howard safran, Brown University:

newly diagnosed; advanced pancreatic cancer; pancreatic cancer; metastatic pancreatic cancer; pancreas

Additional relevant MeSH terms:

Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Digestive System Diseases; Endocrine System Diseases; Oxaliplatin; Albumin-Bound Paclitaxel; Paclitaxel; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Phytogenic; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators