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

Advanced Gastric Cancer Clinical Trial

Official title:

A Single-arm Phase II Trial of Biweekly Docetaxel and S-1 Combination Therapy as Second-line Treatment for Advanced Gastric Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03137004
• Other study ID #: FNF-005
• Status: Not yet recruiting
• Phase: Phase 2
• First received: April 27, 2017
• Last updated: May 5, 2017
• Start date: June 1, 2017
• Est. completion date: October 10, 2018

Study information

• Verified date: May 2017
• Source: Fujian Cancer Hospital
• Contact: Rongbo Lin, MD
• Phone: 008613705919382
• Email: rongbo_lin[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 47
• Est. completion date: October 10, 2018
• Est. primary completion date: April 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Rongbo Lin	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	six-month overall survival		6 months
Secondary	Objective Response Rate (ORR)		6 months
Secondary	Overall Survival (OS)		12 months
Secondary	Progression-Free Survival (PFS)		12 months
Secondary	Adverse Event(AE)		NCI CTC 4.03