mFOLFIRINOX as Adjuvent Chemotherapy in Treating Chinese Pancreatic Cancer Patients

Overview

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

Full Title of Study: “A Phase II Study With mFOLFIRINOX as Adjuvent Chemotherapy for Resectable Pancreas Carcinoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2022

Detailed Description

This is a phase II study. Patients with resectable pancreatic carcinoma will receive adjuvant chemotherapy of FOLFIRINOX for 6 months.

Primary endpoint is the disease free survival. Secondary endpoints are overall survival, safety and quality of life.

Interventions

  • Drug: 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Disease free survival
    • Time Frame: 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

Secondary Measures

  • Overall survival
    • Time Frame: up to 24 months
    • From the date of first drug administration until the date of death

Participating in This Clinical Trial

Inclusion Criteria

Histologically confirmed adenocarcinoma of the pancreas without distant metastases.

Receive radical resection of pancreatic cancer No prior cytostatic chemotherapy Female and male patients > 18 and <=79 years using contraception ECOG ≤ 1 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 Written informed consent

Exclusion Criteria

Pregnant or lactating women Distant 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 ℃.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 79 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yuhong Li, Professor – Sun Yat-sen University
  • Overall Official(s)
    • Yuhong Li, Principal Investigator, Sun Yat-sen University
  • Overall Contact(s)
    • Miaozhen Qiu, 13760612003, qiumzh@sysucc.org.cn

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