MFOLFIRINOX As First-Line Chemotherapy In Treating Chinese Patients With Metastatic Pancreatic Cancer

Study Overview

mFOLFIRINOX as First-Line Chemotherapy in Treating Chinese Patients With Metastatic Pancreatic Cancer

This phase Ⅱ study was designed to evaluate the efficacy and safety of mFOLFIRINOX as first-line treatment for metastatic pancreatic cancer in China.

Although FOLFIRINOX regimen was recently presented to be effective for metastatic pancreatic cancer in selected patients who have good physical condition, there is still insufficient evidence on this regimen in treating patients with metastatic pancreatic cancer in China. Since for many tumors, different races may show different responses to the same regimen, we design this open, multicenter phase Ⅱ study to evaluate the the efficacy and safety of mFOLFIRINOX as first-line treatment for metastatic pancreatic cancer in China.

Metastatic Pancreatic Cancer

DRUG: mFOLFIRINOX

PAN-321

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-01-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-02-14
First Submitted that Met QC Criteria 2014-01-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-02-16
First Posted (ACTUAL) 2014-01-07	Results First Posted N/A	Last Verified 2023-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: FOLFIRINOX Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continu	DRUG: mFOLFIRINOX Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continu

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: FOLFIRINOX

Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continu

DRUG: mFOLFIRINOX

Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continu

Primary Outcome Measures	Measure Description	Time Frame
Disease control rate		Up to 24 weeks

Secondary Outcome Measures	Measure Description	Time Frame
Progression free survival		From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall survival		From the date of first drug administration until the date of death, assessed up to 60 months
Number of participants with AEs and SAEs as a measure of Safety	Safety data will be assessed at each study visit using NCI CTCAE version 3.0	Each follow up visit, assessed up to 24 weeks
EORTC QLQ-C30	Quality of life will be assessed at each study using EORTC QLQ-C30	Each follow up visit, assessed up to 24 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Patients have provided a signed Informed Consent Form
ECOG performance status of 0-1
BMI ≥ 18.5
Age: 18-65 years old
Histologically confirmed diagnosis of metastatic pancreatic cancer
No prior palliative chemotherapy
Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria
Life expectancy ≥ 3 months
Patient has adequate bone marrow and organ function

Absolute Neutrophil Count (ANC) ≥ 2.0 x 109/L
Platelets ≥ 90 x 109/L
Hemoglobin ≥ 90 g/L
Patient has adequate liver function

AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis)
Serum bilirubin ≤ 1.2 x ULN
Creatinine ≤ 1.25 times ULN
Good compliance

Pregnant or lactating women
Brain metastasis or only with bone metastasis.
Patients with severe gastrointestinal hemorrhage which need frequent blood transfusions.
Refuse to take appropriate contraceptive measures (including male patients).
Allergic to Oxaliplatin, Irinotecan, Leucovorin or 5-Fluorouracil.
Severe systemic disease out of control such as unstable or uncompensated respiratory, cardiac, liver, renal diseases.
Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non-melanoma skin cancer or cervical carcinoma in situ).
Psychiatric illness that would prevent the patient from giving informed consent.
Patient is concurrently using other antineoplastic agent
Patient has used investigational antineoplastic agent within 4 weeks prior to entry.
Known HIV-positivity.
No history of chronic diarrhea, nausea or vomit.
No ≥ grade 2 sensory peripheral neuropathy.
A history of transmural myocardial infarction (within 6 months prior to entry), congestive heart failure, and unstable angina.
Infectious disease or inflammation with body temperature ≥ 38 ℃.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Li Yuhong, MD, Sun Yat-sen University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Wang ZQ, Zhang F, Deng T, Zhang L, Feng F, Wang FH, Wang W, Wang DS, Luo HY, Xu RH, Ba Y, Li YH. The efficacy and safety of modified FOLFIRINOX as first-line chemotherapy for Chinese patients with metastatic pancreatic cancer. Cancer Commun (Lond). 2019 May 8;39(1):26. doi: 10.1186/s40880-019-0367-7.

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