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

Yonsei University

Status and phase

Completed

Phase 2

Conditions

Pancreatic Ductal Adenocarcinoma

Treatments

Drug: modified FOLFIRINOX regimen

Study type

Interventional

Funder types

Other

Identifiers

NCT02440958

4-2014-0973

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

19 to 75 years old

Volunteers

No 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