Albumin Bound Paclitaxel Plus S-1 as the First Line Chemotherapy in Advanced or Recurrent Gastric Cancer

Sponsor

Sun Yat-sen University (Other)

Overall Status

Completed

CT.gov ID

NCT02229058

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: Albumin Bound Paclitaxel Drug: S-1	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

73 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Study of Albumin Bound Paclitaxel Plus S-1 as the First Line Chemotherapy in Advanced or Recurrent Gastric Cancer

Actual Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Feb 1, 2017

Actual Study Completion Date :

Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Albumin Bound Paclitaxel 120 mg/m2, D1,D8,every 3 weeks until disease progress or intolerable toxicity. Other Names: abraxane Drug: S-1 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.

Arm

Intervention/Treatment

Experimental: 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.

Drug: Albumin Bound Paclitaxel

120 mg/m2, D1,D8,every 3 weeks until disease progress or intolerable toxicity.

Other Names:

abraxane

Drug: S-1

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.

Outcome Measures

Primary Outcome Measures

Progression-free survival [through study completion, an average of 2 years]
Progression-free survival is determined from the date of treatment to PD or death.

Secondary Outcome Measures

Response rate [up to one year]
the ratio of patients whose efficiency evaluation is CR or PR
Overall survival [OS follow-up period: 18 months or 80% OS events, whichever occurs first.]
the date of treatment to death from any cause or the last follow-up date
Disease control rate [AEs (Adverse events) should be recorded during the study period and six months after last IMP administration]
the ratio of patients whose efficiency evaluation is CR or PR or SD

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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.
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.