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

February 14, 2023 updated by: Yuhong Li

Phase Ⅱ Trial to Investigate the Efficacy and Safety of mFOLFIRINOX in Patients With Metastatic Pancreatic Cancer in China

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 ℃.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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 continuous infusion.
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 continuous infusion.
Other Names:
  • Leucovorin
  • Irinotecan
  • Oxaliplatin
  • 5-Fluorouracial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease control rate
Time Frame: Up to 24 weeks
Up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 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
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
Time Frame: From the date of first drug administration until the date of death, assessed up to 60 months
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
Time Frame: Each follow up visit, assessed up to 24 weeks
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
Time Frame: Each follow up visit, assessed up to 24 weeks
Quality of life will be assessed at each study using EORTC QLQ-C30
Each follow up visit, assessed up to 24 weeks

Collaborators and Investigators

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

Sponsor

Yuhong Li

Investigators

  • Principal Investigator: Li Yuhong, MD, Sun Yat-sen University

Publications and helpful links

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

General Publications

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 Major Dates

Study Start (Actual)

February 1, 2013

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

January 1, 2014

First Submitted That Met QC Criteria

January 4, 2014

First Posted (Estimate)

January 7, 2014

Study Record Updates

Last Update Posted (Actual)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAN-321

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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