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

December 10, 2012
December 10, 2012
September 2012
September 2013   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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.
Same as current
Not Provided
Not Provided
 
Cisplatin,Docetaxel and S-1 for Advanced Gastric and Gastroesophageal Junction Cancer
Phase II Clinical Trial of Cisplatin,Docetaxel and S-1 as First Line Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gastric Cancer
  • Gastroesophageal Junction Cancer
  • Drug: Docetaxel
    Other Name: taxotere
  • Drug: Cisplatin
  • Drug: S-1
    Other Name: TS-1
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.
Interventions:
  • Drug: Docetaxel
  • Drug: Cisplatin
  • Drug: S-1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
May 2014
September 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact: Aiping Zhou, M.D 8610-87788145 zhouap1825@126.com
Contact: Yongkun Sun, M.D 8610-87788145 hsunyk@tom.com
China
 
NCT01747707
CH-GI-31
No
Aiping Zhou, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
Not Provided
Principal Investigator: Aiping Zhou, M.D Cancer Hospital & Institute, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP