Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Advanced Pancreatic Cancer
NCT ID: NCT02135822
Last Updated: 2014-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2014-05-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
gemcitabine
Gemcitabine is given intravenously at 1000 mg/m2 on day 1 and 8 of each 21-day cycle. Number of cycles: 6 cycles.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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Liu, Rong
Professor and chief physician
Principal Investigators
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Rong Liu
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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References
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Xu R, Yu X, Hao J, Wang L, Pan H, Han G, Xu J, Zhang Y, Yang S, Chen J, Ying J, Dai G, Li M, Begic D, Lu B, Shen L. Efficacy and safety of weekly nab-paclitaxel plus gemcitabine in Chinese patients with metastatic adenocarcinoma of the pancreas: a phase II study. BMC Cancer. 2017 Dec 22;17(1):885. doi: 10.1186/s12885-017-3887-z.
Other Identifiers
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ABX-LR001
Identifier Type: -
Identifier Source: org_study_id
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