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Nab-paclitaxel Plus S-1 in Patients With Advanced Pancreatic Cancer (NAPSPAC)

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: NCT02124317
Recruitment Status : Unknown
Verified December 2016 by Dai, Guanghai, Chinese PLA General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 28, 2014
Last Update Posted : December 22, 2016
Sponsor:
Information provided by (Responsible Party):
Dai, Guanghai, 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 S-1 as first-line treatment in Chinese patients with advanced pancreatic ductal adenocarcinoma (PDA).

Condition or disease Intervention/treatment Phase
Advanced Pancreatic Cancer Drug: nanoparticle albumin-bound paclitaxel Drug: S-1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Nab-paclitaxel Plus S-1 in First-line Treatment of Patients With Advanced Pancreatic Cancer
Study Start Date : April 2014
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: nanoparticle albumin-bound paclitaxel, S-1
nanoparticle albumin-bound paclitaxel is given at 120 mg/m2 intravenously on day 1 and 8, in combination with S-1 which is orally administered (40-60 mg according to the body surface, twice a day) on day 1-14 of 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: S-1
S-1 is orally administered (40-60 mg according to the body surface, twice a day) on day 1-14 of each 21 day cycle. Number of cycles: 6 cycles.




Primary Outcome Measures :
  1. Objective response rate [ Time Frame: Measure at every 6 weeks (every 2 cycles) ]
    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 ]
    Measure of time from study treatment to disease progression or death.

  2. Overall survival [ Time Frame: up to 2 years ]
    Measure 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) ]
    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): NCT02124317


Locations
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China, Beijing
Chinese PLA General Hospital
Beijing, Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Principal Investigator: Guanghai Dai Chinese PLA General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dai, Guanghai, Professor and chief physician, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02124317    
Other Study ID Numbers: ABXS001
First Posted: April 28, 2014    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016
Keywords provided by Dai, Guanghai, Chinese PLA General Hospital:
nanoparticle albumin-bound paclitaxel
S-1
advanced pancreatic cancer
objective response rate
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
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action