Cisplatin,Docetaxel and S-1 for Advanced Gastric and Gastroesophageal Junction Cancer

Phase 2

• Conditions: Gastric Cancer; Gastroesophageal Junction Cancer
• Interventions: Drug: Docetaxel; Drug: Cisplatin; Drug: S-1

• Registration Number: NCT01747707
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

The combination of Cisplatin and S-1 (CS) achieved a response rate of approximately 45% with the PFS being around 6 months and overall survival time being 13 months in Japanese and Chinese gastric patients. It remains unclear whether the addition of docetaxel to CS would further enhance the efficacy as it dose in DCF(docetaxel, cisplatin and 5-fluorouracil). This is a single center, phase II clinical trial to evaluate the efficacy of docetaxel, cisplatin and S-1 (DCS) as first line chemotherapy for patients with advanced gastric and gastroesophageal junction cancer.

Detailed Description

This is a single arm trial. All Patients will receive up to 6 cycles of triple chemotherapy with docetaxel, cisplatin and S-1. Given the severe toxicity of DCF regimen, here the total dose of docetaxel and cisplatin is both reduced to 60mg/m2. For patients with CR/PR/SD disease after 6 cycles of chemotherapy, maintenance therapy with S-1 are recommended. Antitumor activity will be evaluated every two cycles according to RECIST1.1.

Study Timeline

• Study Start: 2012-09
• Status Verified: 2012-12
• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2012-12-10
• Last Update Submitted: 2012-12-10
• Study First Posted: 2012-12-12
• Last Update Posted: 2012-12-12
• Primary Completion: 2013-09
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Histologically or cytologically confirmed unresectable advanced gastric or gastroesophageal junction cancer;
• No previous chemotherapy and radiation for advanced disease except palliative radiation for a local pain control;
• At least one evaluable lesion per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1;
• ECOG (Eastern Cooperative Oncology Group) performance status 0-1;
• Recovery from the toxicities of previous therapy;
• Adequate bone marrow and organ function. Hb≥8 G/L; Absolute neutrophil ≥ 2.0 G/L; PLT ≥100 G/L ;ALT/AST ≤1.5 ULN or ≤5ULN with liver metastases; TBIL ≤1.5 ULN; Cr≤1.0 ULN;
• Life expectancy ≥3 months;
• For men and women of childbearing potential, agree on taking effective contraceptive method of birth control from the signed informed consent until 3 months after the last study drug administration;
• Signed informed consent.

Exclusion Criteria

• Pathology type other than adenocarcinoma,such as squamous cell carcinoma;
• Previous treatment with taxanes, cisplatin or S-1;
• Relapse within 6 months after the end of adjuvant chemotherapy;
• Known brain metastases;
• Complete or incomplete intestinal obstruction or uncontrolled gastrointestinal bleeding;
• Known deficiency of DPD enzyme;
• Kown HIV infecton or drug addiction;
• Any acute or chronic medical or psychiatric condition that would make the patient inappropriate for entry into this trial in the judgement of investigators;
• Myocardial infarction within 6 months prior to the entry of this trial;
• Known history of allergic reaction to taxanes and platinum;
• Pregnant or breast feeding women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
docetaxel, cisplatin and S-1 (DCS)	S-1	All patients receive the combination therapy of docetaxel, cisplatin and S-1 for a maximum of 6 cycles. Docetaxel 60mg/m2 IV infusion over 1 hour on d1; Cisplatin 30mg/m2 IV infusion on d1,2; S-1 40mg orally twice a day for patients with the body surface area (BSA) less than 1.25m2, 50mg twice a day with the BSA between 1.25 and 1.5m2, 60mg twice a day with the BSA over 1.5m2.
docetaxel, cisplatin and S-1 (DCS)	Cisplatin	All patients receive the combination therapy of docetaxel, cisplatin and S-1 for a maximum of 6 cycles. Docetaxel 60mg/m2 IV infusion over 1 hour on d1; Cisplatin 30mg/m2 IV infusion on d1,2; S-1 40mg orally twice a day for patients with the body surface area (BSA) less than 1.25m2, 50mg twice a day with the BSA between 1.25 and 1.5m2, 60mg twice a day with the BSA over 1.5m2.
docetaxel, cisplatin and S-1 (DCS)	Docetaxel	All patients receive the combination therapy of docetaxel, cisplatin and S-1 for a maximum of 6 cycles. Docetaxel 60mg/m2 IV infusion over 1 hour on d1; Cisplatin 30mg/m2 IV infusion on d1,2; S-1 40mg orally twice a day for patients with the body surface area (BSA) less than 1.25m2, 50mg twice a day with the BSA between 1.25 and 1.5m2, 60mg twice a day with the BSA over 1.5m2.

Primary Outcome Measures

Name	Time	Method
overall survival time (OS)	14 months	To determine the OS of DCS in patients with chemo-naive, advanced gastric or gastroesophageal junction cancer.

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	6 months	To determine the PFS of DCS in patients with chemo-naive, gastric or gastroesophageal junction cancer
safety profile	4 months	To determine the tolerability of DCS in patients with chemo-naive, gastric or gastroesophageal junction cancer.

Trial Locations

Locations (1)

Cancer Hospital & Institute, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China