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Trial record 38 of 851 for:    Pancreatic Cancer AND Metastatic Pancreatic Cancer

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

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ClinicalTrials.gov Identifier: NCT02028806
Recruitment Status : Recruiting
First Posted : January 7, 2014
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Yuhong Li, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Drug: mFOLFIRINOX Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ⅱ Trial to Investigate the Efficacy and Safety of mFOLFIRINOX in Patients With Metastatic Pancreatic Cancer in China
Study Start Date : February 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Irinotecan

Arm Intervention/treatment
Experimental: 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.
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.
Other Names:
  • Oxaliplatin
  • Irinotecan
  • Leucovorin
  • 5-Fluorouracial




Primary Outcome Measures :
  1. Disease control rate [ Time Frame: Up to 24 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. Overall survival [ Time Frame: From the date of first drug administration until the date of death, assessed up to 60 months ]
  3. Number of participants with AEs and SAEs as a measure of Safety [ Time Frame: Each follow up visit, assessed up to 24 weeks ]
    Safety data will be assessed at each study visit using NCI CTCAE version 3.0

  4. Quality of life [ Time Frame: Each follow up visit, assessed up to 24 weeks ]
    Quality of life will be assessed at each study using EORTC QLQ-C30



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 ℃.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02028806


Contacts
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Contact: Li Yuhong, MD, Ph D liyh@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Li Yuhong, MD, Ph D       liyh@sysucc.org.cn   
Principal Investigator: Li Yuhong, MD, Ph D         
Sponsors and Collaborators
Yuhong Li
Investigators
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Principal Investigator: Li Yuhong, MD Sun Yat-sen University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yuhong Li, MD, Ph D, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02028806     History of Changes
Other Study ID Numbers: PAN-321
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Oxaliplatin
Irinotecan
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action