Clinical trial NCT02124317: Nab-paclitaxel Plus S-1 in Patients With Advanced Pancreatic Cancer
Official title: Phase II Trial of Nab-paclitaxel Plus S-1 in First-line Treatment of Patients With Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Pancreatic Cancer
Keywords: nanoparticle albumin-bound paclitaxel
S-1
advanced pancreatic cancer
objective response rate
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2014-04-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Objective response rate
timeFrame: Measure at every 6 weeks (every 2 cycles)
Secondary outcomes:
measure: Progression-free survival
timeFrame: up to 15 months
measure: Overall survival
timeFrame: up to 2 years
measure: Disease control rate
timeFrame: Measure every 6 weeks (every 2 cycles)
measure: Safety and tolerability
timeFrame: up to 18 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Guanghai Dai
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shi Y, Zhang S, Han Q, Li J, Yan H, Lv Y, Shi H, Liu R, Dai G. Nab-paclitaxel plus S-1 in advanced pancreatic adenocarcinoma (NPSPAC): a single arm, single center, phase II trial. Oncotarget. 2017 Sep 28;8(54):92401-92410. doi: 10.18632/oncotarget.21359. eCollection 2017 Nov 3.