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Nab-paclitaxel Plus S-1 in Patients With Advanced Pancreatic Cancer (NAPSPAC)

Primary Purpose

Advanced Pancreatic Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
nanoparticle albumin-bound paclitaxel
S-1
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Pancreatic Cancer focused on measuring nanoparticle albumin-bound paclitaxel, S-1, advanced pancreatic cancer, objective response rate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed informed-consent form.
  2. Age no less than 18 years.
  3. Histologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma, with RECIST measurable lesions.
  4. Eastern Cooperative Oncology Group (ECOG) 0-1 with life expectation of no less than 12 weeks.
  5. 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.
  6. Adequate liver/bone marrow function.
  7. Human Chorionic Gonadotropin (HCG) test negative for female with contraception measure until 3 months after study end.
  8. Compliant, and can be followed up regularly.

Exclusion Criteria:

  1. Pregnant or breast-feeding female, or not willing to take contraception measures during study.
  2. Serious infection requiring antibiotics intervention during recruitment.
  3. Allergic to study drug.
  4. More than grade 1 neuropathy.
  5. Uncontrolled brain metastasis or mental illness.
  6. Congestive heart failure, uncontrolled cardiac arrhythmia, etc.
  7. Other malignancy within 5 years.
  8. Can't be followed up or obey protocol.
  9. Ineligible by the discretion of the investigator.

Sites / Locations

  • Chinese PLA General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

nanoparticle albumin-bound paclitaxel, S-1

Arm Description

nanoparticle albumin-bound paclitaxel is given at 120 mg/m2 intravenously on day 1 and 8, in combination with S-1 which is orally administered (40-60 mg according to the body surface, twice a day) on day 1-14 of each 21 day cycle. Number of cycle: 6 cycles.

Outcomes

Primary Outcome Measures

Objective 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
Measure of time from study treatment to disease progression or death.
Overall survival
Measure 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

First Posted
April 24, 2014
Last Updated
December 21, 2016
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02124317
Brief Title
Nab-paclitaxel Plus S-1 in Patients With Advanced Pancreatic Cancer
Acronym
NAPSPAC
Official Title
Phase II Trial of Nab-paclitaxel Plus S-1 in First-line Treatment of Patients With Advanced Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
May 2017 (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 S-1 as first-line treatment in Chinese patients with advanced pancreatic ductal adenocarcinoma (PDA).
Detailed Description
Advanced PDA is a lethal disease with a approximately 6 months of median survival. Gemcitabine is always the only approved single agent. The recent results of the phase III trial MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) demonstrated an improvement in overall response rate (ORR), progression free survival (PFS) and overall survival (OS) for the combination of nab-paclitaxel plus gemcitabine compared to gemcitabine alone. Thus, the combination of nab-paclitaxel with gemcitabine became one of a standard treatment in metastatic PDA. S-1 is an oral fluoropyrimidine, and shown to be non-inferior to gemcitabine on OS for unresectable pancreatic cancer, and also demonstrated non-inferior, and even superior to gemcitabine as adjuvant chemotherapy. This single-arm study is to explore the efficacy and safety of nab-paclitaxel plus S-1 as first-line treatment in Chinese patients with local advanced or metastatic pancreatic ductal adenocarcinoma.

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, S-1, advanced pancreatic cancer, objective response rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nanoparticle albumin-bound paclitaxel, S-1
Arm Type
Experimental
Arm Description
nanoparticle albumin-bound paclitaxel is given at 120 mg/m2 intravenously on day 1 and 8, in combination with S-1 which is orally administered (40-60 mg according to the body surface, twice a day) on day 1-14 of 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)
S-1
Intervention Description
S-1 is orally administered (40-60 mg according to the body surface, twice a day) on day 1-14 of each 21 day cycle. Number of cycles: 6 cycles.
Primary Outcome Measure Information:
Title
Objective 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)
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
Measure of time from study treatment to disease progression or death.
Time Frame
up to 15 months
Title
Overall survival
Description
Measure 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)
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guanghai Dai
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

12. IPD Sharing Statement

Citations:
PubMed Identifier
29190925
Citation
Shi Y, Zhang S, Han Q, Li J, Yan H, Lv Y, Shi H, Liu R, Dai G. Nab-paclitaxel plus S-1 in advanced pancreatic adenocarcinoma (NPSPAC): a single arm, single center, phase II trial. Oncotarget. 2017 Sep 28;8(54):92401-92410. doi: 10.18632/oncotarget.21359. eCollection 2017 Nov 3.
Results Reference
derived

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Nab-paclitaxel Plus S-1 in Patients With Advanced Pancreatic Cancer

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