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Patients receive FOLFIRINOX regimen comprising irinotecan hydrochloride IV over 90 minutes, oxaliplatin IV over 120 minutes, leucovorin calcium IV over 120 minutes, and fluorouracil IV over 1-2 minutes and then continuously over 46 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Irinotecan Hydrochloride

Leucovorin Calcium

Laboratory Biomarker Analysis

Davendra Sohal

This phase II trial studies how well combination chemotherapy works in treating patients with pancreatic cancer before undergoing surgery. Drugs used in chemotherapy, such as irinotecan hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil (FOLFIRINOX), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PRIMARY OBJECTIVES:

I. To determine feasibility of preoperative FOLFIRINOX for resectable pancreatic adenocarcinoma.

SECONDARY OBJECTIVES:

I. To determine safety and toxicity of preoperative FOLFIRINOX. II. To determine response rate. III. To determine proportion achieving major pathologic response - per College of American Pathologists (CAP) criteria.

IV. To determine proportion achieving R0 resection. V. To determine perioperative (30-day) mortality. VI. To determine the role of cancer antigen (CA)19.9 as potential prognostic and/or predictive biomarker.

VII. To determine progression-free survival. VIII. To determine overall survival.

OUTLINE:

Patients receive FOLFIRINOX regimen comprising irinotecan hydrochloride intravenously (IV) over 90 minutes, oxaliplatin IV over 120 minutes, leucovorin calcium IV over 120 minutes, and fluorouracil IV over 1-2 minutes and then continuously over 46 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months.

Preoperative Folfirinox for Resectable Pancreatic Adenocarcinoma - A Phase II Study

Proportion will be estimated using a binomial test.

Time from enrollment to the earlier of death or disease progression. Will be estimated with Kaplan Meier curves.

Time from enrollment to death from any cause. Will be estimated with Kaplan Meier curves.

Toxicity evaluation will be enumeration of all major toxicities, with proportions calculated for each.

Will be calculated as a binary outcome. Exact 95% confidence intervals will be calculated for binary outcomes.

National Cancer Institute (NCI)

Case Comprehensive Cancer Center

Patients receive FOLFIRINOX regimen comprising irinotecan hydrochloride IV over 90 minutes, oxaliplatin IV over 120 minutes, leucovorin calcium IV over 120 minutes, and fluorouracil IV over 1-2 minutes and then continuously over 46 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Irinotecan Hydrochloride: Given IV

Oxaliplatin: Given IV

Leucovorin Calcium: Given IV

Fluorouracil: Given IV

Laboratory Biomarker Analysis: Correlative studies

Treatment (FOLFIRINOX)

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Davendra Sohal

Only 1 patient was enrolled on study. Outcome data was not analyzed. Trial closed due to competing studies.

Number of Patients Undergoing Surgical Resection After Receiving at Least 4 of the 6 Courses of Preoperative Chemotherapy

Progression-free Survival

Only 1 patient was enrolled on study. Outcome data was not analyzed.

Overall Survival

Incidence of Toxicities Greater Than Grade 2, Using the Common Terminology Criteria for Adverse Events Version 4.0

Response Rate Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1

Number of Participants Achieving Major Pathologic Response

Number of Participants Achieving R0 Resection

Number of Participants Experiencing Perioperative (30-day) Mortality

Overall Study

Spots Global Cancer Trial Database for undifferentiated pancreatic carcinoma