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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02135822
Recruitment Status : Unknown
Verified May 2014 by Liu, Rong, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : May 12, 2014
Last Update Posted : May 16, 2014
Sponsor:
Information provided by (Responsible Party):
Liu, Rong, 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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : December 2015


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 Name: Gemzar




Primary Outcome Measures :
  1. Overall response rate [ Time Frame: 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 :
  1. Progression-free survival [ Time Frame: up to 15 months ]
    Measurement of time from study treatment to disease progression or death.

  2. Overall survival [ Time Frame: up to 2 years ]
    Measurement of time from study treatment to patient's death or lost to follow-up.

  3. Disease control rate [ Time Frame: 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).

  4. Safety and tolerability [ Time Frame: up to 18 month ]
    Percentage of patients who experience adverse events during this study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135822


Contacts
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Contact: Rong Liu 13801150988 liurong301@126.com
Contact: Fei Wang 13581703001 drwangfei@126.com

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Principal Investigator: Rong Liu         
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Principal Investigator: Rong Liu Chinese PLA General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Liu, Rong, Professor and chief physician, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02135822    
Other Study ID Numbers: ABX-LR001
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: May 2014
Keywords provided by Liu, Rong, Chinese PLA General Hospital:
nanoparticle albumin-bound paclitaxel
gemcitabine
advanced pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs