Phase II Study of Albumin Bound Paclitaxel Plus S-1 as the First Line Chemotherapy in Advanced or Recurrent Gastric Cancer
Overview
- Phase
- Phase 2
- Intervention
- Albumin Bound Paclitaxel
- Conditions
- Gastric Cancer
- Sponsor
- Sun Yat-sen University
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Ruihua Xu
Professor of Medical Oncology,Vice-president of Sun Yat-sen University Cancer Center
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease.
- •Male or female.
- •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.
Arms & Interventions
Albumin Bound Paclitaxel plus S-1
Abraxane 120 mg/m2, D1,D8;S-1 40\~60mg QD D1-D14,every 3 weeks until disease progress or intolerable toxicity.
Intervention: Albumin Bound Paclitaxel
Albumin Bound Paclitaxel plus S-1
Abraxane 120 mg/m2, D1,D8;S-1 40\~60mg QD D1-D14,every 3 weeks until disease progress or intolerable toxicity.
Intervention: S-1
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: through study completion, an average of 2 years
Progression-free survival is determined from the date of treatment to PD or death.
Secondary Outcomes
- Overall survival(OS follow-up period: 18 months or 80% OS events, whichever occurs first.)
- Response rate(up to one year)
- Disease control rate(AEs (Adverse events) should be recorded during the study period and six months after last IMP administration)