Combination Chemotherapy Before and After Surgery in Treating Patients With Localized Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

This phase II trial studies how well combination chemotherapy before and after surgery works in treating patients with localized pancreatic cancer. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

Detailed description public domain (ClinicalTrials.gov)

PRIMARY OBJECTIVES: I. To determine the progression-free survival in patients with resectable non-metastatic pancreatic cancer treated with peri-operative modified leucovorin calcium, fluorouracil, irinotecan hydrochloride, oxaliplatin (mFOLFIRINOX). SECONDARY OBJECTIVES: I. Determine overall survival. II. Determine objective response rate after neoadjuvant mFOLFIRINOX. TERTIARY OBJECTIVES: I. Compare R0 resection rate and pathologic stage with institutional historical controls who did not receive neoadjuvant therapy. II. Correlate early metabolic response, determined by changes in glucose metabolism using positron emission tomography (PET) scanning, with pathologic response, R0 resection, and pathologic stage. III. Correlate early metabolic response, determined by changes in glucose metabolism using PET scanning, with progression-free and overall survival. IV. Correlate pre-operative response of CA19-9 with progression-free and overall survival. V. Collect and bank serial serum and plasma specimens from subjects for future correlative biomarker studies. VI. Collect and bank tumor tissue from subjects prior to treatment (from the diagnostic endoscopic ultrasonography \[EUS\]-guided biopsy) and after treatment with six cycles of FOLFIRINOX (from the surgical specimen) for future correlative biomarker studies. OUTLINE: NEOADJUVANT THERAPY: Patients receive mFOLFIRINOX comprising oxaliplatin intravenously (IV) over 2 hours, levoleucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV continuously for 46 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. SURGERY: Beginning 3-8 weeks after completion of neoadjuvant therapy patients undergo surgical resection. ADJUVANT THERARPY: Beginning within 12 weeks after surgery, patients receive mFOLFIRINOX as in neoadjuvant therapy. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2 months for 3 years, every 6 months for 2 years, and then annually thereafter.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Progression Free Survival Rate [At 12 months]. Number, percentage of participants (90% Confidence Interval). Treatment (mFOLFIRINOX) (n=46): 67 (56.9 to 100).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival [Up to 5 years]. Median, months (95% Confidence Interval). Treatment (mFOLFIRINOX) (n=46): 37.2 (17.5 to NA) [insufficient number of participants with events].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Objective Response Rate [Up to 5 years]. Number, percentage of participants. Treatment (mFOLFIRINOX) (n=46): 17.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression Free Survival Rate [up to 5 years]. Median, months (95% Confidence Interval). Treatment (mFOLFIRINOX) (n=46): 16.6 (13.3 to 40.6).