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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02345460
Other study ID # CASE4214
Secondary ID NCI-2014-02277CA
Status Terminated
Phase Phase 2
First received
Last updated
Start date September 2015
Est. completion date March 2016

Study information

Verified date June 2018
Source Case Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial studies how well combination chemotherapy works in treating patients with pancreatic cancer before undergoing surgery. Drugs used in chemotherapy, such as irinotecan hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil (FOLFIRINOX), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.


Description:

PRIMARY OBJECTIVES:

I. To determine feasibility of preoperative FOLFIRINOX for resectable pancreatic adenocarcinoma.

SECONDARY OBJECTIVES:

I. To determine safety and toxicity of preoperative FOLFIRINOX. II. To determine response rate. III. To determine proportion achieving major pathologic response - per College of American Pathologists (CAP) criteria.

IV. To determine proportion achieving R0 resection. V. To determine perioperative (30-day) mortality. VI. To determine the role of cancer antigen (CA)19.9 as potential prognostic and/or predictive biomarker.

VII. To determine progression-free survival. VIII. To determine overall survival.

OUTLINE:

Patients receive FOLFIRINOX regimen comprising irinotecan hydrochloride intravenously (IV) over 90 minutes, oxaliplatin IV over 120 minutes, leucovorin calcium IV over 120 minutes, and fluorouracil IV over 1-2 minutes and then continuously over 46 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date March 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients must have histologically or cytologically confirmed carcinoma of the pancreas; most cases will be adenocarcinoma; cases with "undifferentiated" or "poorly differentiated" carcinoma will also be eligible

- There should be no evidence of metastatic disease on imaging of the chest, abdomen, and pelvis; this imaging should be either a contrast-enhanced computed tomography (CT) scan, or a contrast-enhanced magnetic resonance imaging (MRI) scan; positron emission tomography (PET) scans alone will not be adequate alternatives; there should be no evidence of occult metastatic disease in the abdomen, confirmed by laparoscopic examination

- The primary tumor must be resectable, defined as no involvement (abutment or encasement) of the major arteries (celiac, common hepatic, superior mesenteric) and interface between tumor and vessel (portal, superior mesenteric veins) wall to be less than 180 degrees of the circumference of the vessel wall; this should be confirmed by imaging of the abdomen, either by a contrast-enhanced computed tomography (CT) scan, or a contrast-enhanced magnetic resonance imaging (MRI) scan; PET scans will not be adequate alternatives; for each patient, the resectability must be reviewed by one of the study surgeons

- Patient must not have received any cancer-directed therapy (e.g., surgery, chemotherapy, radiation therapy, biologic therapy) for the index diagnosis

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Hemoglobin >= 10.0 g/dl

- Absolute neutrophil count >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

- Total bilirubin =< 1.5 X institutional upper limit of normal

- Serum creatinine within normal institutional limits, or creatinine clearance (calculated by Cockcroft-Gault) >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

- Women of child-bearing potential and men must agree to use adequate contraception (double-barrier method of birth control or abstinence) for the duration of study participation and for 6 months after completing chemotherapy; should a woman become pregnant or suspect that she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately

- Subjects must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

- Pregnant or breastfeeding women

- Pre-existing peripheral neuropathy (grade I or higher)

Study Design


Intervention

Drug:
Irinotecan Hydrochloride
Given IV
Oxaliplatin
Given IV
Leucovorin Calcium
Given IV
Fluorouracil
Given IV
Other:
Laboratory Biomarker Analysis
Correlative studies

Locations

Country Name City State
United States Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Cleveland Ohio

Sponsors (2)

Lead Sponsor Collaborator
Case Comprehensive Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Patients Undergoing Surgical Resection After Receiving at Least 4 of the 6 Courses of Preoperative Chemotherapy Proportion will be estimated using a binomial test. Up to 12 weeks
Secondary Progression-free Survival Time from enrollment to the earlier of death or disease progression. Will be estimated with Kaplan Meier curves. Up to 2 years
Secondary Overall Survival Time from enrollment to death from any cause. Will be estimated with Kaplan Meier curves. Up to 2 years
Secondary Incidence of Toxicities Greater Than Grade 2, Using the Common Terminology Criteria for Adverse Events Version 4.0 Toxicity evaluation will be enumeration of all major toxicities, with proportions calculated for each. Up to 30 days after end of treatment or to the day prior to surgery
Secondary Response Rate Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 Will be calculated as a binary outcome. Exact 95% confidence intervals will be calculated for binary outcomes. Up to 2 years
Secondary Number of Participants Achieving Major Pathologic Response Will be calculated as a binary outcome. Exact 95% confidence intervals will be calculated for binary outcomes. Up to 2 years
Secondary Number of Participants Achieving R0 Resection Will be calculated as a binary outcome. Exact 95% confidence intervals will be calculated for binary outcomes. Up to 2 years
Secondary Number of Participants Experiencing Perioperative (30-day) Mortality Will be calculated as a binary outcome. Exact 95% confidence intervals will be calculated for binary outcomes. Up to 30 days
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