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

Phase 2

• Conditions: Advanced Pancreatic Cancer
• Interventions: Drug: nanoparticle albumin-bound paclitaxel; Drug: S-1

• Registration Number: NCT02124317
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-24
• Study First Submitted QC: 2014-04-25
• Study First Posted: 2014-04-28
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Last Update Submitted: 2016-12-21
• Last Update Posted: 2016-12-22
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nanoparticle albumin-bound paclitaxel, S-1	nanoparticle albumin-bound paclitaxel	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.
nanoparticle albumin-bound paclitaxel, S-1	S-1	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.

Primary Outcome Measures

Name	Time	Method
Objective response rate	Measure at every 6 weeks (every 2 cycles)	Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).

Secondary Outcome Measures

Name	Time	Method
Overall survival	up to 2 years	Measure of time from study treatment to patient's death or lost to follow-up.
Disease control rate	Measure every 6 weeks (every 2 cycles)	The sum of rates of partial response, complete response and steady disease based on Response Evaluation Criteria In Solid Tumors (RECIST).
Progression-free survival	up to 15 months	Measure of time from study treatment to disease progression or death.
Safety and tolerability	up to 18 month	Percentage of patients who experience adverse events during this study.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China