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

Primary Purpose

Metastatic Pancreatic Cancer

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

mFOLFIRINOX

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 ℃.

Sites / Locations

Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FOLFIRINOX

Arm Description

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.

Outcomes

Primary Outcome Measures

Disease control rate

Secondary Outcome Measures

Progression free survival

Overall survival

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

EORTC QLQ-C30

Quality of life will be assessed at each study using EORTC QLQ-C30

Full Information

NCT ID

NCT02028806

First Posted

January 1, 2014

Last Updated

February 14, 2023

Sponsor

Yuhong Li

1. Study Identification

Unique Protocol Identification Number

NCT02028806

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

February 2013 (Actual)

Primary Completion Date

December 2020 (Actual)

Study Completion Date

December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yuhong Li

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FOLFIRINOX

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

mFOLFIRINOX

Other Intervention Name(s)

Oxaliplatin, Irinotecan, Leucovorin, 5-Fluorouracial

Intervention Description

Primary Outcome Measure Information:

Title

Disease control rate

Time Frame

Up to 24 weeks

Secondary Outcome Measure Information:

Title

Progression free survival

Time Frame

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

Title

Overall survival

Time Frame

From the date of first drug administration until the date of death, assessed up to 60 months

Title

Number of participants with AEs and SAEs as a measure of Safety

Description

Safety data will be assessed at each study visit using NCI CTCAE version 3.0

Time Frame

Each follow up visit, assessed up to 24 weeks

Title

EORTC QLQ-C30

Description

Quality of life will be assessed at each study using EORTC QLQ-C30

Time Frame

Each follow up visit, assessed up to 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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 ℃.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li Yuhong, MD

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

31068222

Citation

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.

Results Reference

derived

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

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