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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02229058
• Other study ID #: ABI-SG
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2014
• Last updated: July 25, 2017
• Start date: February 2012
• Est. completion date: February 2017

Study information

• Verified date: July 2017
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Albumin Bound Paclitaxel
120 mg/m2, D1,D8,every 3 weeks until disease progress or intolerable toxicity.
• 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.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	Progression-free survival is determined from the date of treatment to PD or death.	through study completion, an average of 2 years
Secondary	Response rate	the ratio of patients whose efficiency evaluation is CR or PR	up to one year
Secondary	Overall survival	the date of treatment to death from any cause or the last follow-up date	OS follow-up period: 18 months or 80% OS events, whichever occurs first.
Secondary	Disease control rate	the ratio of patients whose efficiency evaluation is CR or PR or SD	AEs (Adverse events) should be recorded during the study period and six months after last IMP administration