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Docetaxel and S-1 Combination Therapy as Second-line Treatment for Advanced Gastric Cancer

Primary Purpose

Advanced Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Docetaxel
S-1
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Gastric Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age: 18-75 years old;
  2. Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma;
  3. The patient has experienced disease progression during treatment or within 4 months after the last dose of first-line therapy without taxanes for metastatic disease.
  4. Relapse within 6 months after adjuvant chemotherapy;
  5. ECOG (Eastern Cooperative Oncology Group)performance status 0-2;
  6. At least 1 measurable lesion should be present（RECIST1.1）
  7. Available Organ function: Neutrophils>2g/L, Hemoglobin>9g/L, Blood platelet >100g/L; Alanine aminotransferase(ALT） and Aspartate aminotransferase(AST)<1.5 ULN(upper limit of normal); Total bilirubin(TBIL)<1.0 ULN; Cr <1.0ULN
  8. Signed informed consent.
  9. Life expectancy ≥3 months;

Exclusion Criteria:

  1. Previous treatment with taxanes (not including intraperitoneal use of taxanes);
  2. Known history of hypersensitivity to study drugs;
  3. Active CNS metastases not controllable with radiotherapy or corticosteroids;
  4. Pregnant or breast feeding women;
  5. Severe co-morbid illness and/or active infections;
  6. Active and uncontrollable bleeding from gastrointestinal tract
  7. Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or allopurinol;
  8. Other co-existing malignancies or malignancies diagnosed within the last 5 years(except cured cutaneum carcinoma or carcinoma in situs of cervix);
  9. Known HIV infecton.

Sites / Locations

  • Rongbo Lin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

biweekly DS

Arm Description

The biweekly DS regimen consisted of Docetaxel (50mg/m2) and S-1 (40mg/m2)

Outcomes

Primary Outcome Measures

six-month overall survival

Secondary Outcome Measures

Objective Response Rate (ORR)
Overall Survival (OS)
Progression-Free Survival (PFS)
Adverse Event（AE）

Full Information

First Posted
April 27, 2017
Last Updated
May 5, 2017
Sponsor
Fujian Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03137004
Brief Title
Docetaxel and S-1 Combination Therapy as Second-line Treatment for Advanced Gastric Cancer
Official Title
A Single-arm Phase II Trial of Biweekly Docetaxel and S-1 Combination Therapy as Second-line Treatment for Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Anticipated)
Primary Completion Date
April 10, 2018 (Anticipated)
Study Completion Date
October 10, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A single-arm phase II study to evaluate the efficacy and safety of docetaxel plus S-1 (DS) as second-line treatment in patients with AGC.
Detailed Description
For patients with advanced gastric cancer, combination chemotherapy has been shown to improve the quality of life and overall survival (OS) compared with best supportive care alone. Docetaxel is an active agent for treating patients with gastric cancer. S-1, an oral 5-FU prodrug, is active against AGC as a single agent or in combination with cisplatin in phase III trials. Therefore, a single-arm phase II study was conducted to investigate the efficacy and safety of biweekly docetaxel and S-1 (DS) combination therapy as second-line treatment in patients with previously treated advanced gastric cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
biweekly DS
Arm Type
Experimental
Arm Description
The biweekly DS regimen consisted of Docetaxel (50mg/m2) and S-1 (40mg/m2)
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Docetaxel 50mg/m2 in 60 min on day 1 and repeated every 14 days.
Intervention Type
Drug
Intervention Name(s)
S-1
Other Intervention Name(s)
TS-1
Intervention Description
S-1 was administered orally at 40 mg/m2 twice daily on days 1-7 of each cycle. Patients with a body surface area of less than 1.25 m2 received 80 mg S-1 daily, those with a body surface area of 1.25 m2 or more but less than 1.5 m2 received 100 mg S-1 daily, and those with a body surface area of 1.5 m2 or more received 120 mg S-1 daily.
Primary Outcome Measure Information:
Title
six-month overall survival
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Time Frame
6 months
Title
Overall Survival (OS)
Time Frame
12 months
Title
Progression-Free Survival (PFS)
Time Frame
12 months
Title
Adverse Event（AE）
Time Frame
NCI CTC 4.03

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18-75 years old; Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma; The patient has experienced disease progression during treatment or within 4 months after the last dose of first-line therapy without taxanes for metastatic disease. Relapse within 6 months after adjuvant chemotherapy; ECOG (Eastern Cooperative Oncology Group)performance status 0-2; At least 1 measurable lesion should be present（RECIST1.1） Available Organ function: Neutrophils>2g/L, Hemoglobin>9g/L, Blood platelet >100g/L; Alanine aminotransferase(ALT） and Aspartate aminotransferase(AST)<1.5 ULN(upper limit of normal); Total bilirubin(TBIL)<1.0 ULN; Cr <1.0ULN Signed informed consent. Life expectancy ≥3 months; Exclusion Criteria: Previous treatment with taxanes (not including intraperitoneal use of taxanes); Known history of hypersensitivity to study drugs; Active CNS metastases not controllable with radiotherapy or corticosteroids; Pregnant or breast feeding women; Severe co-morbid illness and/or active infections; Active and uncontrollable bleeding from gastrointestinal tract Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or allopurinol; Other co-existing malignancies or malignancies diagnosed within the last 5 years(except cured cutaneum carcinoma or carcinoma in situs of cervix); Known HIV infecton.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rongbo Lin, MD
Phone
008613705919382
Email
rongbo_lin@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
JIE LIU, MD
Phone
008613860632919
Email
dr2868@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rongbo Lin, MD
Organizational Affiliation
Fujian Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Rongbo Lin
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Docetaxel and S-1 Combination Therapy as Second-line Treatment for Advanced Gastric Cancer

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