A Phase II Study of Neoadjuvant FOLFIRINOX

NCT02178709 | Completed Phase 2 Results DMC

• 1 other identifier: IUCRO-0473
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the rate of pathologic complete response to neoadjuvant FOLFIRINOX in patients with resectable pancreatic cancer using a tissue collection component.

Conditions

Resectable Pancreatic Ductal Adenocarcinoma

Keywords

Pancreatic; Cancer; Resectable

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Pathologic Complete Response

  Pathologic complete response was evaluated using MRI or CT and Evan's criteria for pathologic response following neoadjuvant therapy: I: \<10% to no tumor cells destroyed IIa: 10-50% of tumor cells destroyed IIb: 50-90% of tumor cells destroyed III: \>90% of tumor cells destroyed IIIM: sizable pools of cellular mucin IV: No viable tumor cells (complete pathologic response) IVM: Acellular pools of mucin

  Up to 4 months

Secondary Outcomes (7)

• Number of Patients With Treatment-Related Adverse Events Grade 3 or Above

  Every 15 days for approximately 6 months

• Percentage of Patients Who Successfully Underwent Surgery After Neoadjuvant FOLFIRINOX

  Up to 4 months

• Rate of R0 Resection

  Up to 4 months

• Disease Free Survival

  Up to 3 years

• Overall Survival

  Up to 4 years

Study Arms (1)

FOLFIRINOX

EXPERIMENTAL

FOLFIRINOX consists of the following combination of drugs: 1. Oxaliplatin, 85 mg/m2, IV over 2 hours prior to irinotecan, administered on days 1 and 15 of each 28 day cycle 2. Leucovorin, 400 mg/m2, IV over 2 hours with irinotecan, administered on days 1 and 15 of each 28 day cycle 3. Irinotecan, 180 mg/m2, IV over 90 minutes with leucovorin, administered on days 1 and 15 of each 28 day cycle 4. 5 FU, 400 mg/m2, IV bolus over 2 minutes after irinotecan, administered on days 1 and 15 of each 28 day cycle. 5. 5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection, administered on days 1 and 15 of each 28 day cycle.

Drug: FOLFIRINOX

Interventions

FOLFIRINOX DRUG

FOLFIRINOX consists of the following combination of drugs: 1. Oxaliplatin, 85 mg/m2, IV over 2 hours prior to irinotecan, administered on days 1 and 15 of each 28 day cycle 2. Leucovorin, 400 mg/m2, IV over 2 hours with irinotecan, administered on days 1 and 15 of each 28 day cycle 3. Irinotecan, 180 mg/m2, IV over 90 minutes with leucovorin, administered on days 1 and 15 of each 28 day cycle 4.5 FU, 400 mg/m2, IV bolus over 2 minutes after irinotecan, administered on days 1 and 15 of each 28 day cycle. 5.5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection, administered on days 1 and 15 of each 28 day cycle.

Also known as: Oxaliplatin (Eloxatin), Leucovorin, Irinotecan (Camptosar), 5 FU (Adrucil)

FOLFIRINOX

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years old at the time of informed consent
• Able to provide written informed consent and HIPAA authorization
• ECOG performance status of 0 or 1
• Patient must be eligible for abdominal surgery
• Histologically confirmed adenocarcinoma of the pancreas that has been documented to be resectable by standardized radiographic criteria by a pancreatic surgeon
• Patients must to have tumor tissue collected prior to enrolling on this trial. Up to 10 patients will be accepted with no pre-treatment research tissue collection or tissue collection from an outside institution.
• a.If the tissue is from an outside institution, it must be reviewed at Indiana University Health Pathology Department if a biopsy was performed outside of this institution.
• Women of childbearing potential definition (WOCBP) must have a negative serum or urine pregnancy test performed within 14 days prior to initiation of FOLFIRINOX.
• Any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) is classified as WOCBP if she meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• WOCBP and men must agree to use adequate contraception prior, to study entry, for the duration of study participation, and 8 weeks after the end of treatment.
• Patients must have adequate organ function as defined by the following laboratory values at study entry:
• Hemoglobin ≥ 9 g/dL (transfusions are acceptable)
• ANC ≥ 1.5 x 109/L

You may not qualify if:

• Prior therapy for pancreatic adenocarcinoma
• Other malignancies within the past 3 years except for the following: adequately treated cervical or vulvar carcinoma in situ, treated basal cell or squamous carcinoma of the skin, superficial bladder tumors (Ta, Tis \& T1), ductal carcinoma in situ (DCIS) of the breast and low grade prostate cancer. Any cancer curatively treated \>3 years prior to entry with no clinical evidence of recurrence is permitted.
• Hypersensitivity to 5FU, oxaliplatin (or other platinum agents), irinotecan (or to their excipients).
• Participation in any investigational drug study within 4 weeks preceding the start of study treatment. Patients are not permitted to participate in another investigational drug study while being treated on this protocol.
• Inability to receive a port or PICC line.
• History of or suspected Gilbert's Disease (testing not required if presence is not suspected).
• Baseline peripheral neuropathy/paresthesia grade ≥ 1.
• Active hepatitis B, unless patient has been on antiviral agents for at least 2 months (baseline testing not required).
• Active clinically serious infections (\> grade 2).
• Major surgery or significant traumatic injury within 8 weeks of first study drug. A core pancreatic or liver biopsy does not preclude the patient from the study.
• Unable or unwilling to discontinue use of ketoconazole or St John's wort. Use of phenytoin, carbamazepine, phenobarbital, rifampin and rifabutin is discouraged, but not contraindicated. If patients require phenytoin, carbamazepine or phenobarbital monitoring of drug levels is suggested during the study.
• Pregnant or lactating women.
• Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

folfirinox; Oxaliplatin; Leucovorin; Irinotecan; Fluorouracil

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: Dr. Amikar Sehdev
• Organization: IndianaU

asehdev@iupui.edu

(317) 274-0339

Study Officials

• Michael House, M.D.

  Indiana 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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: July 1, 2014
• Study Start: June 3, 2014
• Primary Completion: February 14, 2018
• Study Completion: October 28, 2019
• Last Updated: April 19, 2022
• Results First Posted: January 31, 2020

Record last verified: 2022-01

Locations

US (1)