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

Primary Purpose

Gastric Caner

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Albumin Bound Paclitaxel
5-FU
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Caner focused on measuring gastric caner, Albumin Bound Paclitaxel, 5-FU/CF, taxanes naive

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Albumin Bound Paclitaxel With 5-FU/CF

Arm Description

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.

Outcomes

Primary Outcome Measures

PFS(Progression-free survival )
The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death

Secondary Outcome Measures

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

Full Information

First Posted
March 8, 2014
Last Updated
August 27, 2014
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02229045
Brief Title
Phase II Study of Albumin Bound Paclitaxel With 5-FU and CF as Second Line in Taxanes Naive Advanced Gastric Cancer
Official Title
Phase II Study of Albumin Bound Paclitaxel With 5-FU and CF as Second Line in Taxanes Naive Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Caner
Keywords
gastric caner, Albumin Bound Paclitaxel, 5-FU/CF, taxanes naive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Albumin Bound Paclitaxel With 5-FU/CF
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Albumin Bound Paclitaxel
Other Intervention Name(s)
Abraxane
Intervention Description
Albumin Bound Paclitaxel 150 mg/m2 (on day 1), every 2 weeks until disease progress or intolerable toxicity.
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Description
5-FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity.
Primary Outcome Measure Information:
Title
PFS(Progression-free survival )
Description
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 Outcome Measure Information:
Title
OS (Overall survival )
Description
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 Pre-specified Outcome Measures:
Title
ORR (Overall tumor response)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruihua Xu, PhD,MD
Phone
862087343228
Email
xurh@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Dongsheng Zhang, PhD,MD
Phone
862087343795
Email
zhangdsh@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruihua Xu, PhD,MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruihua Xu, Ph D,MD
Phone
862087343228
First Name & Middle Initial & Last Name & Degree
Dongsheng Zhang, Ph D,MD
Phone
862087343795
Email
zhangdsh@sysucc.org.cn

12. IPD Sharing Statement

Learn more about this trial

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

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