BrUOG 278: FOLFOX-A For Pancreatic Cancer A Brown University Oncology Research Group Study (278)
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ClinicalTrials.gov Identifier: NCT01744353 |
Recruitment Status :
Completed
First Posted : December 6, 2012
Results First Posted : April 11, 2016
Last Update Posted : February 17, 2020
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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 |
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 |

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
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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
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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
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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 |
- 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.
- 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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744353
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 |
Principal Investigator: | Howard Safran, MD | Brown University |
Responsible Party: | howard safran, Principal Investigator, Brown University |
ClinicalTrials.gov Identifier: | NCT01744353 |
Other Study ID Numbers: |
BrUOG 278 |
First Posted: | December 6, 2012 Key Record Dates |
Results First Posted: | April 11, 2016 |
Last Update Posted: | February 17, 2020 |
Last Verified: | February 2020 |
newly diagnosed advanced pancreatic cancer pancreatic cancer metastatic pancreatic cancer pancreas |
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 |