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Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas

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ClinicalTrials.gov Identifier: NCT03779464
Recruitment Status : Recruiting
First Posted : December 18, 2018
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Tao Zhang, Wuhan Union Hospital, China

Brief Summary:
A randomized multi-center phase II trial of nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine as first-Line treatment for locally advanced or metastatic pancreatic cancer

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Nab-paclitaxel Gemcitabine S1 Drug: S1 or Gemcitabine Phase 2

Detailed Description:
A Phase II, open-label randomized, multicenter trial to compare nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine with respect to overall survival, objective tumor response rate and Progression Free Survival (PFS) in patients diagnosed with locally advanced or metastatic adenocarcinoma of the pancreas.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : September 30, 2021


Arm Intervention/treatment
Experimental: S/nab
Nab-paclitaxel 125 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area < 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area >1.5 m²; D1-14, q3w)
Drug: S1 or Gemcitabine
Gemcitabine 1000 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area < 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area >1.5 m²; D1-14, q3w)

Active Comparator: Gem/nab
Nab-paclitaxel 125 mg/m² (D1, D8, q3w) and Gemcitabine 1000 mg/m² (D1, D8, q3w)
Drug: S1 or Gemcitabine
Gemcitabine 1000 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area < 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area >1.5 m²; D1-14, q3w)




Primary Outcome Measures :
  1. PFS [ Time Frame: 6 month ]
    progression-free survival


Secondary Outcome Measures :
  1. OS [ Time Frame: 1 year ]
    overall survival

  2. ORR [ Time Frame: 6 month ]
    objective response rate

  3. DCR [ Time Frame: 6 month ]
    CR+PR+SD was defined as disease control rate (DCR)

  4. Safety profile :Adverse events of nab-Paclitaxel plus S-1 [ Time Frame: 1 year ]
    Adverse events of nab-Paclitaxel plus S-1



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological or cytological confirmation of pancreatic adenocarcinoma
  • Distant metastatic or unresctable locally advanced diseases
  • CTScan (or MRI if scanner contraindicated) completed within 3 weeks of the start of treatment
  • At least one lesion measurable by RECIST v1.1 criteria
  • Life expectancy> 3 months
  • No previous chemotherapy (adjuvant chemotherapy with gemcitabine authorised if administered more than 6 months prior to inclusion)
  • No previous radiotherapy (unless at least one measurable target lesion outside the irradiation zone)
  • Pain must be monitored before inclusion
  • 18 years < age < 70
  • Performance status: 0-1
  • ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dL
  • ASAT (SGOT), ALAT (SGPT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases found
  • Bilirubin ≤ 1.5 x ULN (patients drained by retrograde technique are includable),
  • creatinine < 120 μmol/L, or MDRD creatinine clearance > 60 mL/min
  • Patient information and signature of informed consent

Exclusion Criteria:

  • Concurrent other effective treatment (including radiotherapy)
  • Resectable patients
  • Allergy history to other drugs in the same class patients with pregnancy or lactation
  • Known severe internal medical diseases
  • Abnormal heart function or relevant history of myocardial infarction and severe arrhythmia
  • Immunocompromised patients, such as HIV positive
  • Uncontrollable mental illness
  • Other conditions the researchers considered ineligible for the study

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): NCT03779464


Contacts
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Contact: Zhenyu lin, MD 86-27-85871982 whxhlzy@hust.edu.cn
Contact: Tao Zhang, MD 86-27-85871982 taozhangxh@hust.edu.cn

Locations
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China, Hubei
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430022
Contact: Yu Hu, MD    027-85726114    284409937@qq.com   
Sponsors and Collaborators
Wuhan Union Hospital, China

Publications of Results:
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Responsible Party: Tao Zhang, Chief of Gastrointestinal Oncology, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT03779464     History of Changes
Other Study ID Numbers: XHZL-001
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tao Zhang, Wuhan Union Hospital, China:
pancreatic cancer
nab-paclitaxel
gemcitabine
S1
Additional relevant MeSH terms:
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Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Pancrelipase
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