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

NCT ID: NCT03137004

Last Updated: 2017-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2018-10-10

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.

Conditions

Advanced Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

biweekly DS

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

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

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

S-1

Intervention Type: 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.

Interventions

Docetaxel

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

Intervention Type: DRUG

S-1

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.

Intervention Type: DRUG

Other Intervention Names

Taxotere; TS-1

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rongbo Lin, MD

Role: STUDY_CHAIR

Fujian Cancer Hospital

Locations

Rongbo Lin

Fuzhou, Fujian, China

Countries

China

Central Contacts

Rongbo Lin, MD

Role: CONTACT

rongbo_lin@163.com

008613705919382

JIE LIU, MD

Role: CONTACT

dr2868@sina.com

008613860632919

Other Identifiers

FNF-005

Identifier Type: -

Identifier Source: org_study_id