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

NCT02229058 | Completed Phase 2

• 1 other identifier: ABI-SG
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

Gastric Cancer; Albumin Bound Paclitaxel; S-1; First Line

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Response rate

  up to one year

• Overall survival

  OS follow-up period: 18 months or 80% OS events, whichever occurs first.

• Disease control rate

  AEs (Adverse events) should be recorded during the study period and six months after last IMP administration

Study Arms (1)

Albumin Bound Paclitaxel plus S-1

EXPERIMENTAL

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; Drug: S-1

Interventions

Albumin Bound Paclitaxel DRUG

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

Also known as: abraxane

Albumin Bound Paclitaxel plus S-1

S-1 DRUG

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.

Albumin Bound Paclitaxel plus S-1

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Albumin-Bound Paclitaxel; S 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Ruihua Xu, M.D,Ph.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medical Oncology,Vice-president of Sun Yat-sen University Cancer Center

Study Record Dates

• First Submitted: March 8, 2014
• First Posted: August 29, 2014
• Study Start: February 1, 2012
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: July 27, 2017

Record last verified: 2017-07

Locations

CN (1)