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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase II Study of Peri-Operative Modified Folfirinox in Localized Pancreatic Cancer

Brief Summary: 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 Summary:

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 THERA
Sponsor: Yale University

Current Primary Outcome: Progression free survival rate [ Time Frame: At 12 months ]

Evaluated using a one-sided 0.10-alpha level exact test. Summarized using Kaplan-Meier curves


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall survival [ Time Frame: Up to 5 years ]
    Summarized using Kaplan-Meier curves.
  • Objective response rate [ Time Frame: Up to 5 years ]


Original Secondary Outcome: Same as current

Information By: Yale University

Dates:
Date Received: January 24, 2014
Date Started: September 2013
Date Completion: December 2019
Last Updated: January 18, 2017
Last Verified: January 2017