Back to resultsNab-paclitaxel Plus Gemcitabine in Chinese Patients With Advanced Pancreatic Cancer (NAPGAP)
Primary Purpose
Advanced Pancreatic Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
nanoparticle albumin-bound paclitaxel
gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Pancreatic Cancer focused on measuring nanoparticle albumin-bound paclitaxel, gemcitabine, advanced pancreatic cancer
Eligibility Criteria
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.
Sites / Locations
- Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
nanoparticle albumin-bound paclitaxel, gemcitabine
Arm Description
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.
Outcomes
Primary Outcome Measures
Overall response rate
Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).
Secondary Outcome Measures
Progression-free survival
Measurement of time from study treatment to disease progression or death.
Overall survival
Measurement of time from study treatment to patient's death or lost to follow-up.
Disease control rate
The sum of rates of partial response, complete response and steady disease based on Response Evaluation Criteria In Solid Tumors (RECIST).
Safety and tolerability
Percentage of patients who experience adverse events during this study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02135822
Brief Title
Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Advanced Pancreatic Cancer
Acronym
NAPGAP
Official Title
Phase II Trial of Nab-paclitaxel Plus Gemcitabine in First-line Treatment of Chinese Patients With Advanced Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Pancreatic Cancer
Keywords
nanoparticle albumin-bound paclitaxel, gemcitabine, advanced pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nanoparticle albumin-bound paclitaxel, gemcitabine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
nanoparticle albumin-bound paclitaxel
Other Intervention Name(s)
nab-paclitaxel, Abraxane, ABI-007
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine is given intravenously at 1000 mg/m2 on day 1 and 8 of each 21-day cycle. Number of cycles: 6 cycles.
Primary Outcome Measure Information:
Title
Overall response rate
Description
Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).
Time Frame
Measure at every 6 weeks (every 2 cycles) up to 18 weeks
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
Measurement of time from study treatment to disease progression or death.
Time Frame
up to 15 months
Title
Overall survival
Description
Measurement of time from study treatment to patient's death or lost to follow-up.
Time Frame
up to 2 years
Title
Disease control rate
Description
The sum of rates of partial response, complete response and steady disease based on Response Evaluation Criteria In Solid Tumors (RECIST).
Time Frame
Measure every 6 weeks (every 2 cycles) up to 18 weeks
Title
Safety and tolerability
Description
Percentage of patients who experience adverse events during this study.
Time Frame
up to 18 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rong Liu
Phone
13801150988
Email
liurong301@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fei Wang
Phone
13581703001
Email
drwangfei@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rong Liu
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rong Liu
12. IPD Sharing Statement
Citations:
PubMed Identifier
29273007
Citation
Xu R, Yu X, Hao J, Wang L, Pan H, Han G, Xu J, Zhang Y, Yang S, Chen J, Ying J, Dai G, Li M, Begic D, Lu B, Shen L. Efficacy and safety of weekly nab-paclitaxel plus gemcitabine in Chinese patients with metastatic adenocarcinoma of the pancreas: a phase II study. BMC Cancer. 2017 Dec 22;17(1):885. doi: 10.1186/s12885-017-3887-z.
Results Reference
derived
Learn more about this trial
Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Advanced Pancreatic Cancer
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