Back to resultsAlbumin Bound Paclitaxel Plus S-1 as the First Line Chemotherapy in Advanced or Recurrent Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Albumin Bound Paclitaxel
S-1
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, Albumin Bound Paclitaxel, S-1, First Line
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.
- No previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study).
- 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:
- Prior palliative chemotherapy.
- Received any investigational drug treatment within 30 days of start of study treatment.
- Patients with active gastrointestinal bleeding.
- 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.
- Neurological toxicity ≥ grade 2 NCI-CTCAE.
Sites / Locations
- Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Albumin Bound Paclitaxel plus S-1
Arm Description
Abraxane 120 mg/m2, D1,D8;S-1 40~60mg QD D1-D14,every 3 weeks until disease progress or intolerable toxicity.
Outcomes
Primary Outcome Measures
Progression-free survival
Progression-free survival is determined from the date of treatment to PD or death.
Secondary Outcome Measures
Response rate
the ratio of patients whose efficiency evaluation is CR or PR
Overall survival
the date of treatment to death from any cause or the last follow-up date
Disease control rate
the ratio of patients whose efficiency evaluation is CR or PR or SD
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02229058
Brief Title
Albumin Bound Paclitaxel Plus S-1 as the First Line Chemotherapy in Advanced or Recurrent Gastric Cancer
Official Title
Phase II Study of Albumin Bound Paclitaxel Plus S-1 as the First Line Chemotherapy in Advanced or Recurrent Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 2012 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
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 s-1 plus Albumin Bound Paclitaxel as first-line therapy in the treatment of patients with advanced gastric cancer.
Detailed Description
As the first phase II clinical trial of fluoropyrimidines plus Nab-PTX in AGC patientsphase II trial, this study aimed to evaluate the efficacy and safety of S-1 plus Nab-PTX as a first-line treatment for patients with metastatic gastric cancer. All patients were orally treated with S-1 in doses of 40 mg (BSA<1.25 m2), 50 mg (1.25≤BSA<1.50 m2) and 60 mg (BSA≥1.50 m2) b.i.d. on days 1-14 in combination with Nab-PTX (240 mg/m2, divided on days 1 and 8, intravenously for 30 minutes) of each 21-day cycle. Treatment was planned for 6 cycles or until progression, unacceptable toxicity, or patient refusal.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric Cancer, Albumin Bound Paclitaxel, S-1, First Line
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Albumin Bound Paclitaxel plus S-1
Arm Type
Experimental
Arm Description
Abraxane 120 mg/m2, D1,D8;S-1 40~60mg QD D1-D14,every 3 weeks until disease progress or intolerable toxicity.
Intervention Type
Drug
Intervention Name(s)
Albumin Bound Paclitaxel
Other Intervention Name(s)
abraxane
Intervention Description
120 mg/m2, D1,D8,every 3 weeks until disease progress or intolerable toxicity.
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
40mg QD D1-D14,every 3 weeks,for BSA<1.25 m2, 50mg QD D1-D14,every 3 weeks,for BSA=1.25～1.5m2, 60mg QD D1-D14,every 3 weeks,for BSA>1.5m2,until disease progress or intolerable toxicity.
Primary Outcome Measure Information:
Title
Progression-free survival
Description
Progression-free survival is determined from the date of treatment to PD or death.
Time Frame
through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
Response rate
Description
the ratio of patients whose efficiency evaluation is CR or PR
Time Frame
up to one year
Title
Overall survival
Description
the date of treatment to death from any cause or the last follow-up date
Time Frame
OS follow-up period: 18 months or 80% OS events, whichever occurs first.
Title
Disease control rate
Description
the ratio of patients whose efficiency evaluation is CR or PR or SD
Time Frame
AEs (Adverse events) should be recorded during the study period and six months after last IMP administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 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.
No previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study).
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:
Prior palliative chemotherapy.
Received any investigational drug treatment within 30 days of start of study treatment.
Patients with active gastrointestinal bleeding.
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.
Neurological toxicity ≥ grade 2 NCI-CTCAE.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruihua Xu, M.D,Ph.D
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
12. IPD Sharing Statement
Learn more about this trial
Albumin Bound Paclitaxel Plus S-1 as the First Line Chemotherapy in Advanced or Recurrent Gastric Cancer
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