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Status unknownNCT02229045Updated Aug 29, 2014

Phase II Study of Albumin Bound Paclitaxel With 5-FU and CF as Second Line in Taxanes Naive Advanced Gastric Cancer

A Phase 2 interventional study of Albumin Bound Paclitaxel and 5-FU in Gastric Caner, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-08-29.

Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the effectiveness and safety of albumin bound paclitaxel plus 5-FU and as second-line therapy in the treatment of taxanes naive patients with advanced gastric cancer.

02

Conditions studied

  • Gastric Caner

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Keywords

  • gastric caner
  • Albumin Bound Paclitaxel
  • 5-FU/CF
  • taxanes naive
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 37 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease.
  • Male or female.
  • Age 18 -75.
  • Previous one line of non-taxane chemotherapy for advanced/metastatic disease.
  • Measurable disease, according to the Response Evaluation Criteria in Solid Tumours(RECIST)
  • ECOG Performance status 0, 1 or 2
  • Haematological, Biochemical and Organ Function: Neutrophil count >2.0 × 10 9/L, platelet count > 100 ×10 9/L. Serum bilirubin\< 1.5 × upper limit of normal (ULN); or, AST or ALT \< 2.5 × ULN (or \< 5 × ULN in patients with liver metastases); or, alkaline phosphatase\< 2.5 × ULN (or > 5 × ULN in patients with liver metastases,Creatinine clearance > 60 mL/min.
  • Signed informed consent.

Exclusion criteria

Exclusion Criteria:

  • No prior chemotherapy for gastric cancer.
  • Received any investigational drug treatment within 30 days of start of study treatment.
  • Patients with active gastrointestinal bleeding.
  • Neurological toxicity ≥ grade 2 NCI-CTCAE.
  • Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
  • History or clinical evidence of brain metastases.
  • Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.
  • Pregnancy women.
  • Subjects with reproductive potential not willing to use an effective method of contraception.
  • Patients with known active infection with HIV.
  • Known hypersensitivity to any of the study drugs
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (estimated)

Study arms

  • Experimental
    Albumin Bound Paclitaxel With 5-FU/CF

    Albumin Bound Paclitaxel 150 mg/m2 (on day 1),5FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity.

    Drug: Albumin Bound Paclitaxel · Drug: 5-FU

Interventions

  • DrugAlbumin Bound Paclitaxel

    Albumin Bound Paclitaxel 150 mg/m2 (on day 1), every 2 weeks until disease progress or intolerable toxicity.

    Also known as: Abraxane

  • Drug5-FU

    5-FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity.

06

What researchers measure

Primary outcomes

  1. PFS(Progression-free survival )

    The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death

    Time frame: 80% PFS events,, an expected average of 10 months

Secondary outcomes

  1. OS (Overall survival )

    Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.

    Time frame: OS follow-up period: 18 months or 80% OS events, whichever occurs first

Other outcomes

  1. ORR (Overall tumor response)

    Overall tumor response: This is defined as the occurrence of either a confirmed complete (CR) or a partial (PR) best overall response as determined by the RECIST criteria from confirmed radiographic evaluations of target and non-target lesions.

    Time frame: 80% PFS events, an expected average of 10 months

07

Study locations

1 of 1 sites recruiting
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510060, China
    • Ruihua Xu, Ph D,MD · Contact · 862087343228
    • Dongsheng Zhang, Ph D,MD · Contact · zhangdsh@sysucc.org.cn · 862087343795
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02229045
Lead sponsor
Sun Yat-sen University
Responsible party
Ruihua Xu (Professor of Medical Oncology,Vice-president of Sun Yat-sen University Cancer Center, Sun Yat-sen University) — Principal investigator
First posted
Aug 29, 2014
Start date
Nov 2010
Primary completion
Dec 2014 (estimated)
Completion
Dec 2014 (estimated)
Last update
Aug 29, 2014

Study contacts

Ruihua Xu, PhD,MD
Contact
xurh@sysucc.org.cn
862087343228
Dongsheng Zhang, PhD,MD
Contact
zhangdsh@sysucc.org.cn
862087343795
Ruihua Xu, PhD,MD
principal investigator · Sun Yat-sen University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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