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

Metastatic Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02028806
• Other study ID #: PAN-321
• Status: Completed
• Phase: Phase 2
• Start date: February 2013
• Est. completion date: December 2020

Study information

• Verified date: February 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ?.

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Yuhong Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease control rate		Up to 24 weeks
Secondary	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
Secondary	Overall survival		From the date of first drug administration until the date of death, assessed up to 60 months
Secondary	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
Secondary	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