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

NCT02047474 | Completed Phase 2 Results

• 3 other identifiers: 1306012255NCI-2013-02349P30CA016359
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 9

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.

Conditions

Acinar Cell Adenocarcinoma of the Pancreas; Duct Cell Adenocarcinoma of the Pancreas; Stage I Pancreatic Cancer; Stage IIA Pancreatic Cancer; Stage IIB Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival Rate

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

  At 12 months

Secondary Outcomes (3)

• Overall Survival

  Up to 5 years

• Objective Response Rate

  Up to 5 years

• Progression Free Survival Rate

  up to 5 years

Study Arms (1)

Treatment (mFOLFIRINOX)

EXPERIMENTAL

NEOADJUVANT THERAPY: Patients receive mFOLFIRINOX comprising oxaliplatin 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.

Drug: oxaliplatin; Drug: leucovorin calcium; Drug: irinotecan hydrochloride; Drug: fluorouracil; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis

Interventions

oxaliplatin DRUG

Given IV

Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP

Treatment (mFOLFIRINOX)

leucovorin calcium DRUG

Given IV

Also known as: CF, CFR, LV

Treatment (mFOLFIRINOX)

irinotecan hydrochloride DRUG

Given IV

Also known as: Campto, Camptosar, CPT-11, irinotecan, U-101440E

Treatment (mFOLFIRINOX)

fluorouracil DRUG

Given IV

Also known as: 5-fluorouracil, 5-Fluracil, 5-FU

Treatment (mFOLFIRINOX)

therapeutic conventional surgery PROCEDURE

Undergo surgical resection

Treatment (mFOLFIRINOX)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (mFOLFIRINOX)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologic or cytologic documentation of pancreatic adenocarcinoma
• Resectable pancreatic adenocarcinoma disease as defined as follows:
• No evidence of extrapancreatic disease by cross sectional imaging, PET scan, or laparoscopy, including nodal involvement beyond the peripancreatic tissues and/or distant metastases;
• No evidence of tumor extension to superior mesenteric artery, hepatic artery, celiac axis, aorta, or inferior vena cava, and no evidence of occlusion or encasement of the superior mesenteric vein or superior mesenteric vein/portal vein confluence, as assessed by computed tomography (CT) using pancreatic protocol (or magnetic resonance imaging \[MRI\] in patients who cannot undergo CT) and EUS
• No prior treatment (chemotherapy, biological therapy, or radiotherapy) for resectable pancreatic cancer
• No prior treatment with oxaliplatin, irinotecan (irinotecan hydrochloride), fluorouracil or capecitabine
• Patients who received chemotherapy \> 5 years ago for malignancies other than pancreatic cancer are eligible
• There is no evidence of the second malignancy at the time of study entry
• \> 4 weeks since major surgery
• No other concurrent anticancer therapy
• Eastern Cooperative Oncology Group (ECOG) performance status: 0-1
• No other malignancy within past five years except basal cell carcinoma of the skin, cervical carcinoma in situ, or non-metastatic prostate cancer
• Paraffin block or slides must be available
• Adequate organ function
• No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung

Sponsors & Collaborators

• Yale University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (9)

Smilow Cancer Hospital at Fairfield

Fairfield, Connecticut, 06824, United States

Location

Smilow Cancer Hospital at Guilford

Guilford, Connecticut, 06437, United States

Location

Smilow Cancer Hospital at St. Francis Hospital

Hartford, Connecticut, 06105, United States

Location

Yale University

New Haven, Connecticut, 06520-8032, United States

Location

Smilow Cancer Hospital at North Haven

North Haven, Connecticut, 06473, United States

Location

Smilow Cancer Hospital at Orange

Orange, Connecticut, 06477, United States

Location

Smilow Cancer Hospital at Torrington

Torrington, Connecticut, 06790, United States

Location

Smilow Cancer Hospital at Trumbull

Trumbull, Connecticut, 06611, United States

Location

Smilow Cancer Hospital at Waterbury

Waterbury, Connecticut, 06708, United States

Location

Related Publications (1)

• Cecchini M, Salem RR, Robert M, Czerniak S, Blaha O, Zelterman D, Rajaei M, Townsend JP, Cai G, Chowdhury S, Yugawa D, Tseng R, Mejia Arbelaez C, Jiao J, Shroyer K, Thumar J, Kortmansky J, Zaheer W, Fischbach N, Persico J, Stein S, Khan SA, Cha C, Billingsley KG, Kunstman JW, Johung KL, Wiess C, Muzumdar MD, Spickard E, Aushev VN, Laliotis G, Jurdi A, Liu MC, Escobar-Hoyos L, Lacy J. Perioperative Modified FOLFIRINOX for Resectable Pancreatic Cancer: A Nonrandomized Controlled Trial. JAMA Oncol. 2024 Aug 1;10(8):1027-1035. doi: 10.1001/jamaoncol.2024.1575.

  PMID: 38900452 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Oxaliplatin; Leucovorin; Irinotecan; Fluorouracil

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Camptothecin; Alkaloids; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Jill Lacy
• Organization: Yale University

jill.lacy@yale.edu

+1 (203) 737-1600

Study Officials

• Jill Lacy, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: January 28, 2014
• Study Start: March 25, 2014
• Primary Completion: August 16, 2022
• Study Completion: January 14, 2024
• Last Updated: March 6, 2026
• Results First Posted: March 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)