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出境医 / 临床实验 / Nab-paclitaxel and Gemcitabine in Metastatic Pancreatic Cancer

Nab-paclitaxel and Gemcitabine in Metastatic Pancreatic Cancer

Study Description
Brief Summary:
This is a single arm, open-label Phase II clinical trial to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine in Treating Patients with metastatic pancreatic cancer.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Drug: Paclitaxel for Injection(Albumin Bound) Drug: Gemcitabine Phase 2

Detailed Description:

While GT (Gemcitabine + Nab-paclitaxel) is one of the preferred regimens for metastatic pancreatic cancer, we have yet to determine the optimum number of cycles for GT treatment regimen. In this single arm, open-label clinical trial, metastatic pancreatic cancer patients will be received nab-paclitaxel 100 mg/m^2 (iv, 30 minutes) and gemcitabine 1000 mg/m^2 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel therapeutic.

The safety and efficacy of each group will be assessed through ORR, PFS, OS and adverse effects as graded by CTC-AE 5.0.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: nab-paclitaxel + gemcitabine
nab-paclitaxel at 100 mg/m^2 on days 1, 8, and 15; gemcitabine at 1000 mg/m^2 on days 1, 8, and 15
Drug: Paclitaxel for Injection(Albumin Bound)
Patients firstly receive nab-paclitaxel 100 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity,death or begin a novel therapeutic.
Other Name: Paclitaxel

Drug: Gemcitabine
Patients secondly receive gemcitabine 1000 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity,death or begin a novel therapeutic.

Outcome Measures
Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: through study completion, an average of 1 year ]
    To evaluate the Overall Response Rate of patients with metastatic pancreatic cancer after treated with nab-paclitaxel plus gemcitabine.

  2. Progression Free Survival [ Time Frame: through study completion, an average of 1 year ]
    To evaluate the Progression Free Survival of patients with metastatic pancreatic cancer after treated with nab-paclitaxel plus gemcitabine.


Secondary Outcome Measures :
  1. overall survival [ Time Frame: through study completion, an average of 1 year ]
    To evaluate the overall survival of patients with metastatic pancreatic cancer after treated with nab-paclitaxel plus gemcitabine.

  2. adverse events [ Time Frame: through study completion, an average of 1 year ]
    adverse events of patients with metastatic pancreatic cancer after treated with nab-paclitaxel plus gemcitabine.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Signed informed content obtained prior to treatment. The patients were fully explained and understood the purpose, contents, predicted efficacy, pharmacological effects, and risks of this study.
  2. target population

    • the patients were confirmed as metastatic pancreatic cancer by histopathology or cytopathology.
    • At least one measurable objective lesion (both primary and metastatic) was identified based on the RECIST1.1 criteria;
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
    • The expected survival after surgery ≥ 3 months
    • The subjects have good compliance, can be treated and followed up, and voluntarily comply with the relevant provisions of this study
    • No contraindications for gemcitabine and nab-paclitaxel.
  3. Age and reproductive status

    • Age ≥ 18 years and ≤ 75 years
    • Subjects of child-bearing age must agree to take effective contraceptive measures during the study period; Serum or urine pregnancy tests must be negative for women of childbearing age 24 hours before the start of chemotherapy;
    • Women must not lactate.

Exclusion Criteria:

  1. The target disease has cerebral metastasis;
  2. medical history and complications

    • patients had uncontrolled serious medical condition that the investigator considered may affect the subject's to receive treatment under the study program, For example, patients with severe medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.
    • Dementia, changing of mental state or any mental illness which could hinder understanding or informed consent or fill out questionnaires;
    • History of allergy or hypersensitivity to any therapeutic ingredient;
    • Combined with other malignant tumors excepted pancreatic cancer within the first 5 years of randomization, excepted well-treated basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical resection, and ductal carcinoma in situ of the breast after radical resection.
    • Previously received systemic therapy for advanced/metastatic pancreatic cancer;
    • Subjects who had previously been pathologically diagnosed with squamous cell carcinoma (no organ limitation) and received neoadjuvant/adjuvant therapy with taxa regimen.
    • Patients who had Grade 2 or above Peripheral neuropathy.
  3. Abnormal results of physical examination and laboratory examination

    • Absolute neutrophil count (ANC) 90g/L 1.5 × 109/L; Platelets (PLT) 90g/L 100 × 109/L; Hemoglobin (Hgb) < 90g/L
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/ alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) >2.5 × institutional upper limit of normal (ULN), >5 × institutional upper limit of normal (ULN) (hepatic metastases); Total bilirubin (TBIL)>1.5 × ULN;
    • Creatinine (CRE)> 1.5 × ULN
    • Prothrombin time (PT) and international normalized ratio (INR) > 1.5 × ULN. Unless the subject had received anticoagulant treatment
  4. Subjects had hepatitis b surface antigen (HBsAg)-positive and hbv-dna titer in peripheral blood greater than or equal to 1000 copy number /L;If HBsAg is positive and the peripheral blood hbv-dna <1000 copy number /L, the subjects will be eligible for inclusion if the investigator considers that chronic hepatitis b is stable and does not increase the risk of subjects.
  5. Human immunodeficiency virus (HIV)- or hepatitis C virus (HCV) positive patients;
  6. Patients combined with other anti-tumor drugs.
  7. Participation in any trial drug treatment or another interventional clinical trial 30 days before screening period.
  8. The researchers considered that there were other conditions that were not suitable for enrollment.
Contacts and Locations

Contacts
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Contact: Xian-Jun Yu, M.D., Ph.D. +86 21 64175590 yuxianjun@fudanpci.org

Locations
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China, Shanghai
FUDAN University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Wen-Quan Wang, MD    86 21 64175590    wangwenquan@fudanpci.org   
Sponsors and Collaborators
Fudan University
CSPC Ouyi Pharmaceutical Co., Ltd.
Investigators
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Study Director: Xian-Jun Yu Fudan University
Tracking Information
First Submitted Date  ICMJE March 15, 2019
First Posted Date  ICMJE April 26, 2019
Last Update Posted Date April 26, 2019
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • Overall Response Rate [ Time Frame: through study completion, an average of 1 year ]
    To evaluate the Overall Response Rate of patients with metastatic pancreatic cancer after treated with nab-paclitaxel plus gemcitabine.
  • Progression Free Survival [ Time Frame: through study completion, an average of 1 year ]
    To evaluate the Progression Free Survival of patients with metastatic pancreatic cancer after treated with nab-paclitaxel plus gemcitabine.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • overall survival [ Time Frame: through study completion, an average of 1 year ]
    To evaluate the overall survival of patients with metastatic pancreatic cancer after treated with nab-paclitaxel plus gemcitabine.
  • adverse events [ Time Frame: through study completion, an average of 1 year ]
    adverse events of patients with metastatic pancreatic cancer after treated with nab-paclitaxel plus gemcitabine.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nab-paclitaxel and Gemcitabine in Metastatic Pancreatic Cancer
Official Title  ICMJE A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer
Brief Summary This is a single arm, open-label Phase II clinical trial to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine in Treating Patients with metastatic pancreatic cancer.
Detailed Description

While GT (Gemcitabine + Nab-paclitaxel) is one of the preferred regimens for metastatic pancreatic cancer, we have yet to determine the optimum number of cycles for GT treatment regimen. In this single arm, open-label clinical trial, metastatic pancreatic cancer patients will be received nab-paclitaxel 100 mg/m^2 (iv, 30 minutes) and gemcitabine 1000 mg/m^2 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel therapeutic.

The safety and efficacy of each group will be assessed through ORR, PFS, OS and adverse effects as graded by CTC-AE 5.0.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Pancreatic Cancer
Intervention  ICMJE
  • Drug: Paclitaxel for Injection(Albumin Bound)
    Patients firstly receive nab-paclitaxel 100 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity,death or begin a novel therapeutic.
    Other Name: Paclitaxel
  • Drug: Gemcitabine
    Patients secondly receive gemcitabine 1000 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity,death or begin a novel therapeutic.
Study Arms  ICMJE Experimental: nab-paclitaxel + gemcitabine
nab-paclitaxel at 100 mg/m^2 on days 1, 8, and 15; gemcitabine at 1000 mg/m^2 on days 1, 8, and 15
Interventions:
  • Drug: Paclitaxel for Injection(Albumin Bound)
  • Drug: Gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 25, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Signed informed content obtained prior to treatment. The patients were fully explained and understood the purpose, contents, predicted efficacy, pharmacological effects, and risks of this study.
  2. target population

    • the patients were confirmed as metastatic pancreatic cancer by histopathology or cytopathology.
    • At least one measurable objective lesion (both primary and metastatic) was identified based on the RECIST1.1 criteria;
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
    • The expected survival after surgery ≥ 3 months
    • The subjects have good compliance, can be treated and followed up, and voluntarily comply with the relevant provisions of this study
    • No contraindications for gemcitabine and nab-paclitaxel.
  3. Age and reproductive status

    • Age ≥ 18 years and ≤ 75 years
    • Subjects of child-bearing age must agree to take effective contraceptive measures during the study period; Serum or urine pregnancy tests must be negative for women of childbearing age 24 hours before the start of chemotherapy;
    • Women must not lactate.

Exclusion Criteria:

  1. The target disease has cerebral metastasis;
  2. medical history and complications

    • patients had uncontrolled serious medical condition that the investigator considered may affect the subject's to receive treatment under the study program, For example, patients with severe medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.
    • Dementia, changing of mental state or any mental illness which could hinder understanding or informed consent or fill out questionnaires;
    • History of allergy or hypersensitivity to any therapeutic ingredient;
    • Combined with other malignant tumors excepted pancreatic cancer within the first 5 years of randomization, excepted well-treated basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical resection, and ductal carcinoma in situ of the breast after radical resection.
    • Previously received systemic therapy for advanced/metastatic pancreatic cancer;
    • Subjects who had previously been pathologically diagnosed with squamous cell carcinoma (no organ limitation) and received neoadjuvant/adjuvant therapy with taxa regimen.
    • Patients who had Grade 2 or above Peripheral neuropathy.
  3. Abnormal results of physical examination and laboratory examination

    • Absolute neutrophil count (ANC) 90g/L 1.5 × 109/L; Platelets (PLT) 90g/L 100 × 109/L; Hemoglobin (Hgb) < 90g/L
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/ alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) >2.5 × institutional upper limit of normal (ULN), >5 × institutional upper limit of normal (ULN) (hepatic metastases); Total bilirubin (TBIL)>1.5 × ULN;
    • Creatinine (CRE)> 1.5 × ULN
    • Prothrombin time (PT) and international normalized ratio (INR) > 1.5 × ULN. Unless the subject had received anticoagulant treatment
  4. Subjects had hepatitis b surface antigen (HBsAg)-positive and hbv-dna titer in peripheral blood greater than or equal to 1000 copy number /L;If HBsAg is positive and the peripheral blood hbv-dna <1000 copy number /L, the subjects will be eligible for inclusion if the investigator considers that chronic hepatitis b is stable and does not increase the risk of subjects.
  5. Human immunodeficiency virus (HIV)- or hepatitis C virus (HCV) positive patients;
  6. Patients combined with other anti-tumor drugs.
  7. Participation in any trial drug treatment or another interventional clinical trial 30 days before screening period.
  8. The researchers considered that there were other conditions that were not suitable for enrollment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Xian-Jun Yu, M.D., Ph.D. +86 21 64175590 yuxianjun@fudanpci.org
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03929094
Other Study ID Numbers  ICMJE CSPAC-22
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xian-Jun Yu, Fudan University
Study Sponsor  ICMJE Fudan University
Collaborators  ICMJE CSPC Ouyi Pharmaceutical Co., Ltd.
Investigators  ICMJE
Study Director: Xian-Jun Yu Fudan University
PRS Account Fudan University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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