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

Sun Yat-sen University

Status and phase

Completed

Phase 2

Conditions

Gastric Cancer

Treatments

Drug: Albumin Bound Paclitaxel

Drug: S-1

Study type

Interventional

Funder types

Other

Identifiers

NCT02229058

ABI-SG

Details and patient eligibility

About

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.

Full 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.

Enrollment

73 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No 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.