Perioperative FOLFIRINOX for Patients With Resectable Pancreatic Adenocarcinoma: A Pilot Study

Phase 1

Terminated

• Conditions: Pancreatic Ductal Adenocarcinoma (PDAC)
• Interventions: Drug: FOLFIRINOX (oxaliplatin, leucovorin, irinotecan)

• Registration Number: NCT02782182
• Lead Sponsor: University of Chicago

Brief Summary

The purpose of this study is to see whether it is possible to give 8 doses of a combination of chemotherapy called FOLFIRINOX before surgery in subjects whose pancreas cancer can be removed with surgery.

Detailed Description

Primary Objective: To evaluate the percentage of pancreatic cancer patients able to complete the full 4 months of preoperative chemotherapy and undergo a resection.

Secondary Objectives

* To assess the percentage of patients able to complete all therapy, including preoperative chemotherapy, surgery, and postoperative therapy.

* To assess treatment-related toxicity during preoperative therapy

* To assess intra-operative and post-operative complications

* To assess the histopathologic (R0/R1) resection rate after preoperative therapy

* To determine disease free survival (DFS) for patients who undergo resection.

* To determine progression free survival (PFS) for all patients

* To determine overall survival (OS) from the date of first treatment

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-05-16
• Study First Submitted QC: 2016-05-20
• Study First Posted: 2016-05-25
• Study Start: 2016-06-28
• Primary Completion: 2018-03-29
• Study Completion: 2018-03-29
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-15
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

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Exclusion Criteria

1. Patients who have had previous chemotherapy or radiotherapy for pancreatic adenocarcinoma prior to entering the study.
2. Pathologic subtypes other than pure adenocarcinoma; acinar cell carcinoma, squamous cell carcinoma, spindle cell carcinoma, neuroendocrine cancer, and mixed types are not eligible.
3. Patients who are receiving any investigational agents.
4. Patients with borderline resectable, locally advanced or metastatic disease.
5. History of allergic reactions attributed to 5-FU, leucovorin, irinotecan or oxaliplatin or to compounds of similar chemical or biologic composition.
6. 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.
7. 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 mFOLFIRINOX, 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.
8. 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.
9. 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.
10. Pre-existing neuropathy greater than grade 1.
11. Inflammatory bowel disease that is uncontrolled or on active treatment (Crohn's disease, ulcerative colitis).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FOLFIRINOX+surgery	FOLFIRINOX (oxaliplatin, leucovorin, irinotecan)	4 cycles of pre-operative FOLFIRINOX, followed by surgery, followed by 2 more cycles of FOLFIRINOX

Primary Outcome Measures

Name	Time	Method
Percentage of patients able to complete 4 months of preoperative chemotherapy and undergo a resection	4 months	Measured by percentage of successes/failures

Secondary Outcome Measures

Name	Time	Method
R0/R1 resection rates	6 months	Measured as proportion of patients with microscopic negative and microscopic residual tumor margin
Disease free survival	Up to 5 years	Defined by date from surgical resection to radiographic recurrence or death
Progression free survival	Up to 5 years	Defined by radiographic progression by RECIST criteria or death
The extent of preoperative chemotherapy, surgery, and adjuvant chemotherapy.	6 months	Reported as a yes/no for each element of therapy.
Presence of adverse events	6 months	Presence of grade 3 and 4 toxicities measured according to NCI CTCAE version 4.0.
Intraoperative and post-op complications	Within 6 weeks post surgery	Any unexpected events as determined by surgical oncologist
Overall survival	Up to 5 years	Defined by date from Cycle 1 Day 1 of preoperative chemotherapy to death from any cause.

Trial Locations

Locations (1)

University of Chicago Comprehensive Cancer Center; 🇺🇸 Chicago, Illinois, United States