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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Metastatic Pancreatic Cancer

Intervention / Treatment
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* Drug: mFOLFIRINOX


Participation Criteria
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Eligibility Criteria
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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 ℃.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FOLFIRINOX<br>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<br>* 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.<br>* Other names: 5-Fluorouracial;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate |  | Up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 |