- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03929094
Nab-paclitaxel and Gemcitabine in Metastatic Pancreatic Cancer
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Fudan University
-
Contact:
- Wen-Quan Wang, MD
- Phone Number: 86 21 64175590
- Email: wangwenquan@fudanpci.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
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.
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:
- The target disease has cerebral metastasis;
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.
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
- 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.
- Human immunodeficiency virus (HIV)- or hepatitis C virus (HCV) positive patients;
- Patients combined with other anti-tumor drugs.
- Participation in any trial drug treatment or another interventional clinical trial 30 days before screening period.
- The researchers considered that there were other conditions that were not suitable for enrollment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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
|
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 Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Xian-Jun Yu, Fudan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Gemcitabine
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- CSPAC-22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metastatic Pancreatic Cancer
-
Memorial Sloan Kettering Cancer CenterRecruitingPancreatic Cancer | Pancreatic Cancer Metastatic | Pancreatic Cancer Stage IV | Metastatic Pancreatic Carcinoma | Metastatic Pancreatic Adenocarcinoma | Pancreatic Carcinoma | Metastatic Pancreatic Cancer | Pancreatic Cancer Non-resectable | Metastatic Pancreatic Ductal Adenocarcinoma | Pancreatic Carcinoma... and other conditionsUnited States
-
Orion Biotechnology Polska Sp. z o.o.Not yet recruitingMetastatic Colorectal Cancer | Metastatic Cancer | Metastatic Breast Cancer | Metastatic Urothelial Carcinoma | Metastatic Gastric Cancer | Metastatic Pancreatic Cancer
-
Dana-Farber Cancer InstituteNational Cancer Institute (NCI)CompletedMetastatic Colorectal Cancer | Metastatic Pancreatic Cancer | Unresectable Pancreatic CancerUnited States
-
Dana-Farber Cancer InstitutePatient-Centered Outcomes Research Institute; National Cancer Institute (NCI); Alliance for Clinical Trials in OncologyCompletedMetastatic Colorectal Cancer | Metastatic Pancreatic Cancer | Unresectable Pancreatic CancerUnited States
-
Memorial Sloan Kettering Cancer CenterRecruitingPancreatic Cancer | Pancreatic Cancer Metastatic | Pancreatic Ductal Adenocarcinoma | Pancreatic Carcinoma | Metastatic Pancreatic Cancer | Metastatic Pancreatic Ductal AdenocarcinomaUnited States
-
University Hospital HeidelbergGerman Cancer Research CenterCompletedColorectal Cancer Metastatic | Pancreatic Cancer MetastaticGermany
-
HonorHealth Research InstituteUniversity of Arizona; Agenus Inc.; Translational Genomics Research InstituteNot yet recruitingPancreatic Cancer Metastatic | Pancreatic Adenocarcinoma MetastaticUnited States
-
Pancreatic Cancer Action NetworkActive, not recruitingMetastatic Pancreatic Adenocarcinoma | Metastatic Pancreatic CancerUnited States
-
Joachim Aerts, MD PhDCompletedMetastatic Pancreatic CancerNetherlands
-
Georgetown UniversityNational Cancer Institute (NCI); Mayo Clinic; Emory University; Indiana University and other collaboratorsTerminatedMetastatic Colorectal Cancer | Pancreatic Adenocarcinoma | Colorectal Adenocarcinoma | Metastatic Pancreatic CancerUnited States
Clinical Trials on Paclitaxel for Injection(Albumin Bound)
-
China Medical University, ChinaRecruiting
-
Sun Yat-sen UniversityJiangsu HengRui Medicine Co., Ltd.UnknownNon-Small Cell Lung CancerChina
-
Peking UniversityChia Tai Tianqing Pharmaceutical Group Co., Ltd.Not yet recruitingGastric Cancer | Adenocarcinoma of Esophagogastric JunctionChina
-
Sun Yat-sen UniversityShanghai Junshi Bioscience Co., Ltd.; CSPC Ouyi Pharmaceutical Co., Ltd.RecruitingEsophageal Small Cell CarcinomaChina
-
Fuzhou General HospitalUnknownNasopharyngeal CarcinomaChina
-
Nanfang Hospital, Southern Medical UniversityNot yet recruitingNeoadjuvant Therapy | Esophageal Carcinoma
-
Shanghai Yizhong Pharmaceutical Co., Ltd.RecruitingMetastatic Breast Cancer (MBC)China
-
Guangzhou Institute of Respiratory DiseaseJiangsu HengRui Medicine Co., Ltd.; BGI-ShenzhenCompletedEsophageal Squamous Cell Carcinoma | ImmunotherapyChina
-
Fujian Medical University Union HospitalNot yet recruitingChemotherapy | Radiation TherapyChina
-
Peking University First HospitalMerck Sharp & Dohme LLCNot yet recruitingAdvanced Non-squamous Non-small-cell Lung Cancer | Metastatic Non-squamous Non Small Cell Lung Cancer | Recurrent Non-Squamous Non-Small Cell Lung CancerChina