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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Chinese Academy of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Aiping Zhou, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01747707
First received: December 10, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Gastroesophageal Junction Cancer
Drug: Docetaxel
Drug: Cisplatin
Drug: S-1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial of Cisplatin,Docetaxel and S-1 as First Line Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • overall survival time (OS) [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    To determine the OS of DCS in patients with chemo-naive, advanced gastric or gastroesophageal junction cancer.


Secondary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To determine the PFS of DCS in patients with chemo-naive, gastric or gastroesophageal junction cancer

  • safety profile [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    To determine the tolerability of DCS in patients with chemo-naive, gastric or gastroesophageal junction cancer.


Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: docetaxel, cisplatin and S-1 (DCS)
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.
Drug: Docetaxel
Other Name: taxotere
Drug: Cisplatin Drug: S-1
Other Name: TS-1

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747707

Contacts
Contact: Aiping Zhou, M.D 8610-87788145 zhouap1825@126.com
Contact: Yongkun Sun, M.D 8610-87788145 hsunyk@tom.com

Locations
China
Cancer Hospital & Institute, Chinese Academy of Medical Sciences Recruiting
Beijing, China, 10021
Contact: Yongkun Sun, M.D    8610-87788145    hsunyk@tom.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Aiping Zhou, M.D Cancer Hospital & Institute, Chinese Academy of Medical Sciences
  More Information

No publications provided

Responsible Party: Aiping Zhou, Associate professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01747707     History of Changes
Other Study ID Numbers: CH-GI-31
Study First Received: December 10, 2012
Last Updated: December 10, 2012
Health Authority: China: State Food and Drug Adminstration

Keywords provided by Chinese Academy of Medical Sciences:
gastric cancer
gastroesophageal junction cancer
chemotherapy
docetaxel
cisplatin
S-1

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014