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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Trial of Nab-paclitaxel Plus S-1 in First-line Treatment of Patients With Advanced Pancreatic Cancer

Conditions
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Advanced Pancreatic Cancer

Intervention / Treatment
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* Drug: nanoparticle albumin-bound paclitaxel
* Drug: S-1


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nanoparticle albumin-bound paclitaxel, S-1<br>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. | Drug: nanoparticle albumin-bound paclitaxel<br>* 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.<br>* Other names: ABI-007;Drug: S-1<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Measure of time from study treatment to disease progression or death. | up to 15 months | 
| Overall survival | Measure of time from study treatment to patient's death or lost to follow-up. | up to 2 years | 
| Disease control rate | 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) | 
| Safety and tolerability | Percentage of patients who experience adverse events during this study. | up to 18 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nanoparticle albumin-bound paclitaxel, S-1, advanced pancreatic cancer, objective response rate