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

NCT03137004 | Unknown Phase 2

• 1 other identifier: FNF-005
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• six-month overall survival

  6 months

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  6 months

• Overall Survival (OS)

  12 months

• Progression-Free Survival (PFS)

  12 months

• Adverse Event（AE）

  NCI CTC 4.03

Study Arms (1)

biweekly DS

EXPERIMENTAL

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

Drug: Docetaxel; Drug: S-1

Interventions

Docetaxel DRUG

Docetaxel 50mg/m2 in 60 min on day 1 and repeated every 14 days.

Also known as: Taxotere

biweekly DS

S-1 DRUG

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.

Also known as: TS-1

biweekly DS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Rongbo Lin

Fuzhou, Fujian, 350014, China

Location

MeSH Terms

Interventions

Docetaxel; S 1 (combination); titanium silicide

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Rongbo Lin, MD

  Fujian Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Rongbo Lin, MD

CONTACT

008613705919382; rongbo_lin@163.com

JIE LIU, MD

CONTACT

008613860632919; dr2868@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 2, 2017
• Study Start: June 1, 2017
• Primary Completion: April 10, 2018
• Study Completion: October 10, 2018
• Last Updated: May 8, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)