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

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhong Li
• Treatments: Irinotecan; Leucovorin; Oxaliplatin

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 ℃.