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

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

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.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: Albumin Bound Paclitaxel; Drug: S-1

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 Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate	the ratio of patients whose efficiency evaluation is CR or PR	up to one year
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.
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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Ruihua Xu, M.D,Ph.D, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2012
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: March 8, 2014
• First Submitted That Met QC Criteria: August 27, 2014
• First Posted (Estimate): August 29, 2014

Study Record Updates

• Last Update Posted (Actual): July 27, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Gastric Cancer; S-1; First Line; Albumin Bound Paclitaxel
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: ABI-SG