Nab-paclitaxel Plus S-1(AS) Versus Nab-paclitaxel Plus Gemcitabine(AG) in Patients With Advanced Pancreatic Cancer (ASAGPAC)

August 15, 2018 updated by: Shen Lin, Peking University

Phase II Trial Comparing Nab-paclitaxel Plus S-1 Versus Nab-paclitaxel Plus Gemcitabine in First-line Treatment of Patients With Advanced Pancreatic Cancer

This is a randomized phase II trial comparing the first-line treatment with nab-paclitaxel plus S-1(AS) and nab-paclitaxel plus gemcitabine(AG) in advanced pancreatic ductal adenocarcinoma (PDA) with primary tumor nonexcision in Chinese patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Advanced pancreatic ductal adenocarcinoma (PDAC) is an aggressive and chemo-resistant disease with extremely low 5-year survival rate. Gemcitabine has been the cornerstone of metastatic PDAC treatment for more than a decade , although survival benefit was very poor. Nab-paclitaxel added to gemcitabine has showed improving survival and overall response rate vs gemcitabine alone in metastatic PDAC first-line treatment in the MPACT phaseIII study, which represents one of the standards of care in advanced PDAC therapy. S-1 is an oral 5-fluorouracil (5-FU) prodrug, and shown to be non-inferior to gemcitabine on OS for unresectable pancreatic cancer. Meanwhile, adjuvant chemotherapy with S-1 monotherapy was found to significant prolong survival of pancreatic cancer patients when compared with gemcitabine. This study is to explore the efficacy and safety of nab-paclitaxel plus S-1(AS) and nab-paclitaxel plus gemcitabine(AG) as first-line treatment in advanced pancreatic ductal adenocarcinoma (PDA) with primary tumor nonexcision in Chinese patients.

Study Type

Interventional

Enrollment (Anticipated)

40

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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Peking University Cancer Hospital and Institute
        • Contact:
          • Jun Zhou, MD

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:

  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 locally advanced or metastatic disease.
  6. At least 4 weeks since completion of the last operation except for diagnostic biopsy.
  7. At least 4 weeks since completion of radiotherapy to lesions.
  8. Not suitable for local treatment.
  9. Adequate liver/bone marrow function.
  10. Human Chorionic Gonadotropin (HCG) test negative for female with contraception measure until 3 months after study end.
  11. Compliant, and can be followed up regularly.

Exclusion Criteria:

  1. Received chemotherapy or investigational therapy for the treatment of locally advanced or metastatic disease.
  2. Pregnant or breast-feeding female, or not willing to take contraception measures during study.
  3. Serious infection requiring antibiotics intervention during recruitment.
  4. Allergic to study drug.
  5. More than grade 1 neuropathy.
  6. Uncontrolled brain metastasis or mental illness.
  7. Congestive heart failure, uncontrolled cardiac arrhythmia, etc.
  8. Other malignancy within 5 years.
  9. Can't be followed up or obey protocol.
  10. 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AS：Nanoparticle albumin-bound paclitaxel，S-1

Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 of each 14 day cycle.

S-1 is orally administered (BSA<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid) on day 1-7 of each 14 day cycle.
Drug: nanoparticle albumin-bound paclitaxel
Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 of each 14 day cycle or day 1 and 8 of 21 day cycle.
Other Names:
  • ABI-007
  • Abraxane
  • nab-paclitaxel
Drug: S1
S-1 is orally administered (BSA<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid) on day 1-7 of each 14 day cycle.
Active Comparator: AG：Nanoparticle albumin-bound paclitaxel，Gemcitabine

Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 and 8 of each 21 day cycle.

Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21 day cycle.
Drug: nanoparticle albumin-bound paclitaxel
Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 of each 14 day cycle or day 1 and 8 of 21 day cycle.
Other Names:
  • ABI-007
  • Abraxane
  • nab-paclitaxel
Drug: Gemcitabine
Gemcitabine is given at 1000mg/m2 intravenously on d1 and 8 of each 21 day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST)(every 3 cycles in AS or every 2 cycles in AG).
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate of primary tumor
Time Frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST)(every 3 cycles in AS or every 2 cycles in AG).
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Progression-free survival
Time Frame: up to 15 months
Measure of time from study treatment to disease progression or death.
up to 15 months
Overall survival
Time Frame: up to 2 years
Measure of time from study treatment to patient's death or lost to follow-up.
up to 2 years
Disease control rate
Time Frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
The sum of rates of partial response, complete response and steady disease based on Response Evaluation Criteria In Solid Tumors (RECIST).
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
The incidence of treatment related emergent adverse events（Safety and Tolerance）
Time Frame: Until 28 days after the deadline of enrollment
Adverse reactions evaluation is based on the National Cancer Institute adverse event General terminology Standard [CTCAE] 4.0 version
Until 28 days after the deadline of enrollment

Collaborators and Investigators

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

Sponsor

Peking University

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.

General Publications

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 (Actual)

July 17, 2018

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

August 1, 2018

First Submitted That Met QC Criteria

August 15, 2018

First Posted (Actual)

August 17, 2018

Study Record Updates

Last Update Posted (Actual)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASAG01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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