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

NCT ID: NCT02028806

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2020-12-31

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.

Conditions

Metastatic Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

mFOLFIRINOX

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Oxaliplatin; Irinotecan; Leucovorin; 5-Fluorouracial

Eligibility Criteria

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 ℃.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yuhong Li

OTHER

Sponsor Role: lead

Responsible Party

Yuhong Li

MD, Ph D

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Li Yuhong, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

References

Wang ZQ, Zhang F, Deng T, Zhang L, Feng F, Wang FH, Wang W, Wang DS, Luo HY, Xu RH, Ba Y, Li YH. The efficacy and safety of modified FOLFIRINOX as first-line chemotherapy for Chinese patients with metastatic pancreatic cancer. Cancer Commun (Lond). 2019 May 8;39(1):26. doi: 10.1186/s40880-019-0367-7.

Reference Type: DERIVED

PMID: 31068222 (View on PubMed)

Other Identifiers

PAN-321

Identifier Type: -

Identifier Source: org_study_id