NAPGAP: Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Advanced Pancreatic Cancer

Sponsor

Chinese PLA General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02135822

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Pancreatic Cancer	Drug: nanoparticle albumin-bound paclitaxel Drug: gemcitabine	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Trial of Nab-paclitaxel Plus Gemcitabine in First-line Treatment of Chinese Patients With Advanced Pancreatic Cancer

Study Start Date :

May 1, 2014

Anticipated Primary Completion Date :

May 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: nanoparticle albumin-bound paclitaxel, 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.	Drug: nanoparticle albumin-bound paclitaxel 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. Other Names: nab-paclitaxel Abraxane ABI-007 Drug: gemcitabine Gemcitabine is given intravenously at 1000 mg/m2 on day 1 and 8 of each 21-day cycle. Number of cycles: 6 cycles. Other Names: Gemzar

Arm

Intervention/Treatment

Experimental: nanoparticle albumin-bound paclitaxel, 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.

Drug: nanoparticle albumin-bound paclitaxel

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.

Other Names:

nab-paclitaxel

Abraxane

ABI-007

Drug: gemcitabine

Gemcitabine is given intravenously at 1000 mg/m2 on day 1 and 8 of each 21-day cycle. Number of cycles: 6 cycles.

Other Names:

Gemzar

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.