Nab-paclitaxel Plus Gemcitabine in Chinese 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 gemcitabine as first-line treatment in Chinese patients with advanced pancreatic ductal adenocarcinoma.

Detailed Description
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Advanced pancreatic ductal adenocarcinoma is a fatal disease with about 6 months of median overall survival (OS). Gemcitabine is the only approved single agent. Gemcitabine-based chemotherapy did not show benefit in OS during the past decade. The recent phase III trial MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) demonstrated an improvement in overall response rate (ORR), progression free survival (PFS) and OS, with nab-paclitaxel (125 mg/m2 on day 1, 8 and 15 every 28 days) plus gemcitabine (1000 mg/m2 on day 1, 8 and 15 every 28 days) compared to gemcitabine alone. Accordingly the combination of nab-paclitaxel with gemcitabine became one of standard treatments in metastatic pancreatic cancer. A Chinese phase II trial showed the modified dosage of nab-paclitaxel (120 mg/m2 on day 1 and 8 every 21 days) plus gemcitabine (1000 mg/m2 on day 1 and 8 every 21 days) is more suitable for Chinese patients. This study aims to explore the efficacy and safety of the tentative dosage of nab-paclitaxel (125 mg/m2 on day 1 and 8, every 21 days) and gemcitabine (1000 mg/m2 on day 1 and 8, every 21 days) for Chinese patients.

Official Title
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Phase II Trial of Nab-paclitaxel Plus Gemcitabine in First-line Treatment of Chinese 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: gemcitabine


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, gemcitabine<br>Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 and 8, in combination with gemcitabine which is given at 1000 mg/m2, on day 1 and 8, 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: gemcitabine<br>* Gemcitabine is given intravenously at 1000 mg/m2 on day 1 and 8 of each 21-day cycle. Number of cycles: 6 cycles.<br>* Other names: Gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall 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) up to 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Measurement of time from study treatment to disease progression or death. | up to 15 months | 
| Overall survival | Measurement 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) up to 18 weeks | 
| 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, gemcitabine, advanced pancreatic cancer