Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Advanced Pancreatic Cancer
- Conditions
- Advanced Pancreatic Cancer
- Interventions
- Registration Number
- NCT02135822
- 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 gemcitabine as first-line treatment in Chinese patients with advanced pancreatic ductal adenocarcinoma.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description nanoparticle albumin-bound paclitaxel, gemcitabine nanoparticle albumin-bound paclitaxel 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. nanoparticle albumin-bound paclitaxel, gemcitabine gemcitabine 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.
- Primary Outcome Measures
Name Time Method Overall response rate Measure at every 6 weeks (every 2 cycles) up to 18 weeks 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 Progression-free survival up to 15 months Measurement of time from study treatment to disease progression or death.
Overall survival up to 2 years Measurement of time from study treatment to patient's death or lost to follow-up.
Disease control rate Measure every 6 weeks (every 2 cycles) up to 18 weeks The sum of rates of partial response, complete response and steady disease based on Response Evaluation Criteria In Solid Tumors (RECIST).
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