Nab-paclitaxel And Gemcitabine In Metastatic Pancreatic Cancer

Study Overview

Nab-paclitaxel and Gemcitabine in Metastatic Pancreatic Cancer

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.

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.

Metastatic Pancreatic Cancer

DRUG: Paclitaxel for Injection（Albumin Bound）
DRUG: Gemcitabine

CSPAC-22

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-03-15	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-04-25
First Submitted that Met QC Criteria 2019-04-25	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-04-26
First Posted (ACTUAL) 2019-04-26	Results First Posted N/A	Last Verified 2019-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/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 ther 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 thera

Participant Group/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 ther

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 thera

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

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Xian-Jun Yu, M.D., Ph.D.

Phone Number: +86 21 64175590

Email: yuxianjun@fudanpci.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

CSPC Ouyi Pharmaceutical Co., Ltd.

Investigators

STUDY_DIRECTOR: Xian-Jun Yu, Fudan University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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