Modified FOLFIRINOX for Gemcitabine Refractory Pancreatic Cancer: A Phase II Multicenter Trial

Phase 2

Completed

• Conditions: Pancreatic Ductal Adenocarcinoma
• Interventions: Drug: modified FOLFIRINOX regimen

• Registration Number: NCT02440958
• Lead Sponsor: Yonsei University

Brief Summary

Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. Surgery remains the only treatment offering an advantage in terms of overall survival (5-year survival range, 15-25%), but unfortunately only 10-20% of patients present resectable disease at the time of diagnosis. Since the approval of gemcitabine as a standard treatment for advanced pancreatic patients, no drug or combination of drugs has significantly improved the prognosis. Recently, as compared with gemcitabine, FOLFIRINOX was associated with a survival advantage (11.1 vs 6.8 months), but had increased toxicity. In some retrospective studies, modified FOLFIRINOX regimen (60/120 mg/m2 of oxaliplatin and irinotecan) has an improved safety profile in digestive malignancies. The purpose of this phase II multicenter study was to investigate the efficacy and safety in patients with pancreatic cancer who progressed in gemcitabine-based first line chemotherapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-07
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-12
• Study Start: 2015-08-28
• Primary Completion: 2017-03-02
• Study Completion: 2017-03-02
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Pathologically confirmed pancreatic ductal adenocarcinoma (metastatic or locally advanced stage)
• Refractory or progress to Gemcitabine based 1st line chemotherapy
• Older than 19 years old and younger than 75 years old
• Life expectancy> 3 months
• ECOG Performance status ≤2
• Only patients with measurable lesions in imaging study
• Adequete BM function (WBC ≥ 3,500/µl, absolute neutrophil cell count ≥ 1,500 /µl, platelet count ≥ 100,000/µl)
• Adequete liver function (total bilirubin < 1.5 X the upper limits of normal (ULN), AST and ALT <3 X UNL, and alkaline phosphatases < 3 X ULN or < 5 x ULN in case of liver involvement)
• Adequete renal function (serum creatinine < 1.5 mg/dl)
• Adequete cardiopulmonary function

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Exclusion Criteria

• Pathologically confirmed another type of pancreatic cancer (except ductal adenocarcinoma)
• Metastatic adenocarcinoma of originating at other organs
• Evidence with CNS metastasis
• Active infection
• Uncontrolled serious medical or psychiatric illness which can induce toxicity ro complication of treatment, such as inability to swallow, lacking physical integrity of the gastrointestinal tract, malabsorption syndrome, or active ulceration at upper gastrointestinal tract.
• Coexisting of other malignancies within 5 years, except squamous cell carcinoma and basal cell carcinoma of the skin
• Participation in any other investigational drug study within 1 month
• No signed informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
modified FOLFIRINOX	modified FOLFIRINOX regimen	-

Primary Outcome Measures

Name	Time	Method
True response rate	within 16 weeks

Secondary Outcome Measures

Name	Time	Method
Overall survival	6, 12 months