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

Phase 2

Completed

• Conditions: Metastatic Pancreatic Cancer
• Interventions: Drug: mFOLFIRINOX

• Registration Number: NCT02028806
• Lead Sponsor: Yuhong Li

Brief Summary

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

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 Timeline

• Study Start: 2013-02
• Study First Submitted: 2014-01-01
• Study First Submitted QC: 2014-01-04
• Study First Posted: 2014-01-07
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FOLFIRINOX	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.

Primary Outcome Measures

Name	Time	Method
Disease control rate	Up to 24 weeks

Secondary Outcome Measures

Name	Time	Method
Number of participants with AEs and SAEs as a measure of Safety	Each follow up visit, assessed up to 24 weeks	Safety data will be assessed at each study visit using NCI CTCAE version 3.0
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
EORTC QLQ-C30	Each follow up visit, assessed up to 24 weeks	Quality of life will be assessed at each study using EORTC QLQ-C30
Overall survival	From the date of first drug administration until the date of death, assessed up to 60 months

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China