Clinical trial NCT02028806: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Pancreatic Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-01-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 ℃.

Primary outcomes:
measure: Disease control rate
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Progression free survival
timeFrame: 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
measure: Overall survival
timeFrame: From the date of first drug administration until the date of death, assessed up to 60 months
measure: Number of participants with AEs and SAEs as a measure of Safety
timeFrame: Each follow up visit, assessed up to 24 weeks
measure: EORTC QLQ-C30
timeFrame: Each follow up visit, assessed up to 24 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Li Yuhong, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.