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Nab-paclitaxel and Gemcitabine in Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03929094
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
CSPC Ouyi Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Xian-Jun Yu, Fudan University

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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


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.




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.



Information from the National Library of Medicine

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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.

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): NCT03929094


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

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Responsible Party: Xian-Jun Yu, Principal Investigator, Fudan University
ClinicalTrials.gov Identifier: NCT03929094     History of Changes
Other Study ID Numbers: CSPAC-22
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs