Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas

July 4, 2019 updated by: Tao Zhang, Wuhan Union Hospital, China

Phase II Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas

A randomized multi-center phase II trial of nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine as first-Line treatment for locally advanced or metastatic pancreatic cancer

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

A Phase II, open-label randomized, multicenter trial to compare nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine with respect to overall survival, objective tumor response rate and Progression Free Survival (PFS) in patients diagnosed with locally advanced or metastatic adenocarcinoma of the pancreas.

Study Type

Interventional

Enrollment (Anticipated)

132

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 Contact Backup

Study Locations

    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histological or cytological confirmation of pancreatic adenocarcinoma
  • Distant metastatic or unresctable locally advanced diseases
  • CTScan (or MRI if scanner contraindicated) completed within 3 weeks of the start of treatment
  • At least one lesion measurable by RECIST v1.1 criteria
  • Life expectancy> 3 months
  • No previous chemotherapy (adjuvant chemotherapy with gemcitabine authorised if administered more than 6 months prior to inclusion)
  • No previous radiotherapy (unless at least one measurable target lesion outside the irradiation zone)
  • Pain must be monitored before inclusion
  • 18 years < age < 70
  • Performance status: 0-1
  • ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dL
  • ASAT (SGOT), ALAT (SGPT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases found
  • Bilirubin ≤ 1.5 x ULN (patients drained by retrograde technique are includable),
  • creatinine < 120 μmol/L, or MDRD creatinine clearance > 60 mL/min
  • Patient information and signature of informed consent

Exclusion Criteria:

  • Concurrent other effective treatment (including radiotherapy)
  • Resectable patients
  • Allergy history to other drugs in the same class patients with pregnancy or lactation
  • Known severe internal medical diseases
  • Abnormal heart function or relevant history of myocardial infarction and severe arrhythmia
  • Immunocompromised patients, such as HIV positive
  • Uncontrollable mental illness
  • Other conditions the researchers considered ineligible for the study

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S/nab
Nab-paclitaxel 125 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area < 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area >1.5 m²; D1-14, q3w)
Gemcitabine 1000 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area < 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area >1.5 m²; D1-14, q3w)
Active Comparator: Gem/nab
Nab-paclitaxel 125 mg/m² (D1, D8, q3w) and Gemcitabine 1000 mg/m² (D1, D8, q3w)
Gemcitabine 1000 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area < 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area >1.5 m²; D1-14, q3w)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 6 month
progression-free survival
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 1 year
overall survival
1 year
ORR
Time Frame: 6 month
objective response rate
6 month
DCR
Time Frame: 6 month
CR+PR+SD was defined as disease control rate (DCR)
6 month
Safety profile :Adverse events of nab-Paclitaxel plus S-1
Time Frame: 1 year
Adverse events of nab-Paclitaxel plus S-1
1 year

Collaborators and Investigators

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

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 (Anticipated)

August 1, 2019

Primary Completion (Anticipated)

December 30, 2020

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

December 17, 2018

First Submitted That Met QC Criteria

December 17, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

July 8, 2019

Last Update Submitted That Met QC Criteria

July 4, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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