Nab-paclitaxel Plus S-1 in Patients With Advanced Pancreatic Cancer
Conditions
Advanced Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Conditions: Keywords
nanoparticle albumin-bound paclitaxel, S-1, advanced pancreatic cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: nanoparticle albumin-bound paclitaxel Type: Drug
Name: S-1 Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Location
Chinese PLA General Hospital
Beijing, Beijing, China
Status: Recruiting
Contact: Guanghai Dai - daigh60@sohu.com
Start Date
April 2014
Completion Date
December 2015
Sponsors
Chinese PLA General Hospital
Source
Chinese PLA General Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page