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

Primary Purpose

Pancreatic Ductal Adenocarcinoma

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

modified FOLFIRINOX regimen

About this trial

This is an interventional treatment trial for Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

modified FOLFIRINOX

Arm Description

Outcomes

Primary Outcome Measures

True response rate

Secondary Outcome Measures

Overall survival

Full Information

NCT ID

NCT02440958

First Posted

May 7, 2015

Last Updated

February 14, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02440958

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

August 28, 2015 (undefined)

Primary Completion Date

March 2, 2017 (Actual)

Study Completion Date

March 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Ductal Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

modified FOLFIRINOX

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

modified FOLFIRINOX regimen

Intervention Description

Modified FOLFIRINOX regimen consisted of oxaliplatin at a dose of 60 mg per square meter, given as a 2-hour intravenous infusion, after 60 minutes, of irinotecan at a dose of 120 mg per square meter, given as a 90-minute intravenous infusion, immediately followed by leucovorin at a dose of 400 mg per square meter, given as a 2-hour intravenous infusion through a Y-connector. This treatment was immediately followed by fluorouracil at a dose of 400 mg per square meter, administered by intravenous bolus, followed by a continuous intravenous infusion of 2400 mg per square meter over a 46-hour period every 2 weeks

Primary Outcome Measure Information:

Title

True response rate

Time Frame

within 16 weeks

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

6, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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

12. IPD Sharing Statement

Learn more about this trial

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

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