- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02135822
Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Advanced Pancreatic Cancer (NAPGAP)
May 15, 2014 updated by: Liu, Rong, Chinese PLA General Hospital
Phase II Trial of Nab-paclitaxel Plus Gemcitabine in First-line Treatment of Chinese Patients With Advanced Pancreatic Cancer
The purpose of this study is to determine the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) plus gemcitabine as first-line treatment in Chinese patients with advanced pancreatic ductal adenocarcinoma.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Advanced pancreatic ductal adenocarcinoma is a fatal disease with about 6 months of median overall survival (OS).
Gemcitabine is the only approved single agent.
Gemcitabine-based chemotherapy did not show benefit in OS during the past decade.
The recent phase III trial MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) demonstrated an improvement in overall response rate (ORR), progression free survival (PFS) and OS, with nab-paclitaxel (125 mg/m2 on day 1, 8 and 15 every 28 days) plus gemcitabine (1000 mg/m2 on day 1, 8 and 15 every 28 days) compared to gemcitabine alone.
Accordingly the combination of nab-paclitaxel with gemcitabine became one of standard treatments in metastatic pancreatic cancer.
A Chinese phase II trial showed the modified dosage of nab-paclitaxel (120 mg/m2 on day 1 and 8 every 21 days) plus gemcitabine (1000 mg/m2 on day 1 and 8 every 21 days) is more suitable for Chinese patients.
This study aims to explore the efficacy and safety of the tentative dosage of nab-paclitaxel (125 mg/m2 on day 1 and 8, every 21 days) and gemcitabine (1000 mg/m2 on day 1 and 8, every 21 days) for Chinese patients.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
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: Rong Liu
- Phone Number: 13801150988
- Email: liurong301@126.com
Study Contact Backup
- Name: Fei Wang
- Phone Number: 13581703001
- Email: drwangfei@126.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100853
- Recruiting
- Chinese PLA General Hospital
-
Principal Investigator:
- Rong Liu
-
-
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed informed-consent form.
- Age no less than 18 years.
- Histologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma, with RECIST measurable lesions.
- Eastern Cooperative Oncology Group (ECOG) 0-1 with life expectation of no less than 12 weeks.
- Patients must have received no previous chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-fluorouracil or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
- Adequate liver/bone marrow function.
- Human Chorionic Gonadotropin (HCG) test negative for female with contraception measure until 3 months after study end.
- Compliant, and can be followed up regularly.
Exclusion Criteria:
- Pregnant or breast-feeding female, or not willing to take contraception measures during study.
- Serious infection requiring antibiotics intervention during recruitment.
- Allergic to study drug.
- More than grade 1 neuropathy.
- Uncontrolled brain metastasis or mental illness.
- Congestive heart failure, uncontrolled cardiac arrhythmia, etc.
- Other malignancy within 5 years.
- Can't be followed up or obey protocol.
- Ineligible by the discretion of the investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: nanoparticle albumin-bound paclitaxel, gemcitabine
Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 and 8, in combination with gemcitabine which is given at 1000 mg/m2, on day 1 and 8, each 21-day cycle.
Number of cycle: 6 cycles.
|
Nanoparticle albumin-bound paclitaxel is given at 120 mg/m2 intravenously on day 1 and 8 of each 21-day cycle.
Number of cycles: 6 cycles.
Other Names:
Gemcitabine is given intravenously at 1000 mg/m2 on day 1 and 8 of each 21-day cycle.
Number of cycles: 6 cycles.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate
Time Frame: Measure at every 6 weeks (every 2 cycles) up to 18 weeks
|
Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).
|
Measure at every 6 weeks (every 2 cycles) up to 18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability
Time Frame: up to 18 month
|
Percentage of patients who experience adverse events during this study.
|
up to 18 month
|
Progression-free survival
Time Frame: up to 15 months
|
Measurement of time from study treatment to disease progression or death.
|
up to 15 months
|
Overall survival
Time Frame: up to 2 years
|
Measurement of time from study treatment to patient's death or lost to follow-up.
|
up to 2 years
|
Disease control rate
Time Frame: Measure every 6 weeks (every 2 cycles) up to 18 weeks
|
The sum of rates of partial response, complete response and steady disease based on Response Evaluation Criteria In Solid Tumors (RECIST).
|
Measure every 6 weeks (every 2 cycles) up to 18 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rong Liu, Chinese PLA General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 Major Dates
Study Start
May 1, 2014
Primary Completion (ANTICIPATED)
May 1, 2015
Study Completion (ANTICIPATED)
December 1, 2015
Study Registration Dates
First Submitted
May 8, 2014
First Submitted That Met QC Criteria
May 8, 2014
First Posted (ESTIMATE)
May 12, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
May 16, 2014
Last Update Submitted That Met QC Criteria
May 15, 2014
Last Verified
May 1, 2014
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
- ABX-LR001
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 Advanced Pancreatic Cancer
-
Zhejiang UniversityRecruitingAdvanced Colorectal Cancer | Advanced Hepatocellular Carcinoma | Advanced Gastric Cancer | Advanced Pancreatic CancerChina
-
Danae Hamouda, MDRecruitingAdvanced Solid Tumor | Advanced Pancreatic CancerUnited States
-
Rui-hua Xu, MD, PhDNot yet recruitingAdvanced Pancreatic CancerChina
-
Mayo ClinicNational Cancer Institute (NCI)CompletedAdvanced Pancreatic Carcinoma | Metastatic Pancreatic Carcinoma | Stage II Pancreatic Cancer AJCC v8 | Stage III Pancreatic Cancer AJCC v8 | Stage IV Pancreatic Cancer AJCC v8 | Unresectable Pancreatic Carcinoma | Pancreatic Neoplasm | Locally Advanced Pancreatic CarcinomaUnited States
-
Istituto Scientifico Romagnolo per lo Studio e...CompletedUnresectable Pancreatic Cancer | Locally Advanced Pancreatic Cancer | Nonmetastatic Pancreatic CancerItaly
-
University of UtahNational Cancer Institute (NCI)Active, not recruitingStage II Pancreatic Cancer AJCC v8 | Stage III Pancreatic Cancer AJCC v8 | Borderline Resectable Pancreatic Adenocarcinoma | Stage IIA Pancreatic Cancer AJCC v8 | Stage IIB Pancreatic Cancer AJCC v8 | Locally Advanced Unresectable Pancreatic Adenocarcinoma | Locally Advanced Pancreatic Ductal...United States
-
Centre Leon BerardRecruitingMetastatic Pancreatic Cancer | Advanced Pancreatic CancerFrance
-
Washington University School of MedicineNational Cancer Institute (NCI)RecruitingCervical Cancer | Pancreatic Cancer | Pancreas Cancer | Locally Advanced Cervical Carcinoma | Locally Advanced Cervical Cancer | Cancer of the Pancreas | Locally Advanced Pancreatic Carcinoma | Locally Advanced Pancreatic Cancer | Cancer of the Cervix | Locally Advanced Pancreas CancerUnited States
-
National Cancer Institute (NCI)SuspendedStage II Pancreatic Cancer AJCC v8 | Stage III Pancreatic Cancer AJCC v8 | Locally Advanced Pancreatic Adenocarcinoma | Locally Advanced Unresectable Pancreatic Adenocarcinoma | Unresectable Pancreatic AdenocarcinomaUnited States
-
Azienda Ospedaliero-Universitaria di ModenaRecruitingMetastatic Pancreatic Cancer | Advanced Pancreatic CancerItaly
Clinical Trials on nanoparticle albumin-bound paclitaxel
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingRecurrent Breast Carcinoma | Stage IV Breast Cancer AJCC v6 and v7 | Stage III Breast Cancer AJCC v7 | Stage IIIA Breast Cancer AJCC v7 | Stage IIIB Breast Cancer AJCC v7 | Stage IIIC Breast Cancer AJCC v7 | Metastatic Breast Carcinoma | Locally Advanced Breast CarcinomaUnited States
-
University of WashingtonNational Cancer Institute (NCI); Celgene CorporationCompletedRecurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung CancerUnited States
-
Anne NoonanNational Cancer Institute (NCI)RecruitingStage IV Pancreatic Cancer AJCC v8 | Metastatic Pancreatic AdenocarcinomaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnRecurrent Bladder Urothelial Carcinoma | Stage IV Bladder Urothelial CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic... and other conditionsUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingInvasive Breast Carcinoma | Triple-Negative Breast Carcinoma | Breast AdenocarcinomaUnited States
-
Emory UniversityNational Cancer Institute (NCI)Active, not recruitingStage IV Pancreatic Cancer AJCC v8 | Metastatic Pancreatic Adenocarcinoma | Advanced Pancreatic AdenocarcinomaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnAnatomic Stage III Breast Cancer AJCC v8 | Anatomic Stage IIIA Breast Cancer AJCC v8 | Anatomic Stage IIIB Breast Cancer AJCC v8 | Anatomic Stage IIIC Breast Cancer AJCC v8 | Prognostic Stage III Breast Cancer AJCC v8 | Prognostic Stage IIIA Breast Cancer AJCC v8 | Prognostic Stage IIIB Breast... and other conditions
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedPancreatic Adenocarcinoma | Stage III Pancreatic Cancer AJCC v6 and v7 | Locally Advanced Pancreatic Adenocarcinoma | Borderline Resectable Pancreatic Adenocarcinoma | Stage II Pancreatic Cancer AJCC v6 and v7 | Stage IIA Pancreatic Cancer AJCC v6 and v7 | Stage IIB Pancreatic Cancer AJCC v6 and...United States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingStage III Pancreatic Cancer AJCC v8 | Stage IV Pancreatic Cancer AJCC v8 | Unresectable Pancreatic CarcinomaUnited States