Overview

This trial is active, not recruiting.

Condition metastatic pancreatic cancer
Treatment folfox-a
Phase phase 1
Sponsor Brown University
Collaborator Lifespan
Start date November 2012
End date September 2014
Trial size 35 participants
Trial identifier NCT01744353, BrUOG 278

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
FOLFOX-A Dose levels -1, 1, 2, 3: Three patients will be accrued to level 1. If no dose limiting toxicities (defined in section 5.2) are observed after two cycles of treatment, then accrual to level 2 will proceed. This procedure will continue until level 3 provided that the MTD has not been reached. If a DLT is observed in one of the first 3 patients in a dose level, then accrual for that level will be expanded to 6 patients. Two or more instances of DLT in a cohort of 6 patients will result in the preceding dose level being defined as the MTD. If dose level 1 is not tolerable then dose level -1 will be investigated. Once the MTD is found, the Principal Investigator will determine which dose should be assessed futher and an additional 10 patients will be treated.
folfox-a 5-FU infusion, leuocovorin, oxaliplatin, Abraxane
Three patients will be accrued to level 1. If no dose limiting toxicities (defined in section 5.2) are observed after two cycles of treatment, then accrual to level 2 will proceed. This procedure will continue until level 3 provided that the MTD has not been reached. If a DLT is observed in one of the first 3 patients in a dose level, then accrual for that level will be expanded to 6 patients. Two or more instances of DLT in a cohort of 6 patients will result in the preceding dose level being defined as the MTD. If dose level 1 is not tolerable then dose level -1 will be investigated.Once the MTD is found, the Principal Investigator will determine which dose should be assessed futher and an additional 10 patients will be treated.

Primary Outcomes

Measure
Toxicity of FOLFOX-Abraxane (A) for patients with newly diagnosed, advanced pancreatic cancer.
time frame: 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.
time frame: pre-drug until disease progression, whichever comes first, for an expected average of 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title BrUOG 278:FOLFOX-A For Pancreatic Cancer :A Brown University Oncology Research Group Study
Principal investigator Howard Safran, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Brown University.