A Pilot Study of Pre- and Post-surgery Chemotherapy With mFOLFIRINOX in Localized, Resectable Pancreatic Adenocarcinoma

NCT01660711 | Completed Phase 2 Results DMC

• 1 other identifier: EH12-267
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to demonstrate that it is possible to administer chemotherapy prior to and following surgery for pancreatic cancer which is considered operable. The chemotherapy chosen is that which has been shown to be the most effective in treating metastatic disease, and the goal is both to investigate whether this is tolerable and also to investigate the efficacy of this approach in terms of disease response and survival.

Conditions

Pancreatic Adenocarcinoma

Keywords

neoadjuvant; chemotherapy; resectable; adjuvant; pancreas; cancer; adenocarcinoma; surgery

Outcome Measures

Primary Outcomes (1)

• Percentage Able to Complete Full Course of Preoperative Chemotherapy

  The percentage of participants able to complete the full course of preoperative chemotherapy and undergo a resection. This will be the primary determinant of success for this pilot study. - Early withdrawals due to toxicity, disease progression, or intercurrent illness will be considered failures.

  Following completion of all planned therapy, an expected average of 4 months

Secondary Outcomes (1)

• Percentage Able to Complete Full Course of Therapy

  On completion of all planned therapy, an expected average of 8 months

Other Outcomes (3)

• Treatment Related Toxicity

  1 year

• R0 Resection Rate

  3 months

• Progression-free and Overall Survival

  5 years

Study Arms (1)

FOLFIRINOX chemotherapy

EXPERIMENTAL

5FU 2400 mg/m2 IV over 48 hours Irinotecan 180 mg/m2 IV day 1 Oxaliplatin 85 mg/m2 IV day 1 Leucovorin 400 mg/m2 IV day 1 Cycles administered every 14 days for 4 cycles before and 4 cycles after surgery.

Drug: 5 Fluorouracil; Drug: Leucovorin; Drug: Irinotecan; Drug: Oxaliplatin

Interventions

5 Fluorouracil DRUG

2400 mg/m2 by continuous intravenous infusion over 46 hours

Also known as: Adrucil,5FU

FOLFIRINOX chemotherapy

Leucovorin DRUG

400 mg/m2 by IV infusion over 2 hours

Also known as: Folinic acid, Wellcovorin, citrovorum factor

FOLFIRINOX chemotherapy

Irinotecan DRUG

180 mg/m² IV infusion on Day 1 over 90-120 minutes (infusion via a Y connector during the infusion of leucovorin)

Also known as: camptosar, CPT11

FOLFIRINOX chemotherapy

Oxaliplatin DRUG

85 mg/m² IV infusion on Day 1 over 2 hours

Also known as: Eloxatin,

FOLFIRINOX chemotherapy

Eligibility Criteria

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

You may qualify if:

• Histologic or cytologic diagnosis of adenocarcinoma of the pancreas.
• Resectable primary tumor of the head, body or tail of the pancreas defined as a visible mass in the pancreas and:
• No extrapancreatic disease
• A patent superior mesenteric (SMV)- portal vein (PV) confluence (assuming the technical ability to resect and reconstruct this venous confluence if needed)
• A definable tissue plane between the tumor and regional arterial structures including the celiac axis, common hepatic artery, and SMA.
• Confirmation of resectability by surgical oncology consultation.
• Presentation at a multidisciplinary conference at either University of Chicago or NorthShore University
• No previous therapy for pancreatic cancer
• Short removable metal stents rather than plastic stents are preferred but not required for palliation of initial obstructive jaundice
• Karnofsky performance status 80 or better
• Age \> 21 years
• No currently active second malignancy
• No CVA within 6 months, no MI within 6 months
• The effects of mFOLFIRINOX on the developing human fetus are unknown. For this reason and because chemotherapy agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
• Negative pregnancy test in females of reproductive age

You may not qualify if:

• Patients who have had previous chemotherapy or radiotherapy for pancreatic adenocarcinoma prior to entering the study.
• Pathologic subtypes other than pure adenocarcinoma; acinar cell carcinoma, squamous cell carcinoma, spindle cell carcinoma, neuroendocrine cancer, and mixed types are not eligible.
• Patients who are receiving any investigational agents.
• Patients with borderline resectable, locally advanced or metastatic disease.
• History of allergic reactions attributed to 5FU, leucovorin, irinotecan or oxaliplatin or to compounds of similar chemical or biologic composition.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active liver disease including viral or non-viral hepatitis and cirrhosis, chronic diarrhea or inflammatory disease of the colon or rectum, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study. mFOLFIRINOX is a regimen containing more than one chemotherapy agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with FOLFIRINOX, breastfeeding should be discontinued if the mother is treated with these agents. These potential risks may also apply to other agents used in this study.
• HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with mFOLFIRINOX. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
• Currently active second malignancy other than non-melanoma skin cancer or carcinoma in-situ of the cervix. Patients are not considered to have a "currently active" malignancy if they have completed therapy and have no evidence of recurrence for at least 5 years.
• Pre-existing neuropathy greater than grade 1.
• Anticoagulants other than low molecular weight heparin.

Sponsors & Collaborators

• Endeavor Health: lead
• University of Chicago: collaborator

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Neoplasms; Adenocarcinoma

Interventions

Fluorouracil; Leucovorin; Irinotecan; Oxaliplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Robert Marsh
• Organization: NorthShore University/University of Chicago

rmarsh@northshore.org

847-5702112

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: PRINCIPAL INVESTIGATOR
• PI Title: Section Chief Gastrointestinal Oncology, Clinical Professor University of Chicago

Study Record Dates

• First Submitted: August 3, 2012
• First Posted: August 9, 2012
• Study Start: July 1, 2012
• Primary Completion: August 22, 2018
• Study Completion: August 22, 2018
• Last Updated: November 8, 2021
• Results First Posted: November 8, 2021

Record last verified: 2021-11

Locations

US (1)