A Study of Genomic-guided 'Standard-of-care' Chemotherapy for in Advanced Gastric Cancer Patients

This study is currently recruiting participants.
Verified January 2014 by National University Hospital, Singapore
Sponsor:
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01100801
First received: April 7, 2010
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

The investigators hypothesize that the response signature would enable us to stratify patients according to predicted drug response to standard-of-care therapy and hence increase treatment response in an enriched patient group.


Condition Intervention Phase
Advanced Gastric Cancer
Drug: Cisplatin, TS-1 and oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Estimated Enrollment: 25
Study Start Date: July 2010
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Histologically or cytologically documented locally advanced, metastatic or recurrent gastric cancer for which convention therapy of a platinum/fluoropyrimidine combination is indicated
  • Predicted 'responder' to platinum and fluoropyrimidine based on tumour expression signature derived from in-vitro sensitivity array
  • At least one measurable defined by RECIST
  • Age >=21 years old
  • Performance status (ECOG) 0-2
  • Life expectancy >3 months
  • No significant problems for oral intake and drug administration
  • Adequate organ functions:

bone marrow function (ANC = 1,500/uL, Platelet = 100,000/ uL, Hb = 8.0 g/dl) renal function: serum creatinine = UNL (if serum creatinine > ULN, creatinine clearance should be = 60 mL/min) hepatic function (Total bilirubin < 2 x UNL and AST/ALT levels < 3 x ULN without liver metastasis, total bilirubin < 3x ULN and AST/ALT levels < 5 x ULN with liver metastasis)

  • Recovery from relevant toxicity to previous treatment before study entry
  • Ability to understand and willingness to sign a written informed consent before study entry

Exclusion Criteria:

  • Prior chemotherapy for gastric cancer except neoadjuvant or adjuvant systemic therapy if terminated at least 6 months before the start of treatment in this study
  • Prior radiotherapy was administered to target lesions selected for this study
  • Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
  • Presence of symptomatic or progressing CNS metastasis
  • Serious illness or medical conditions:

Congestive heart failure (NYHA class III or IV), unstable angina or myocardial infarction within the past 3 months Hepatic cirrhosis (= Child class B) Psychiatric disorder that may interfere with protocol compliance Active infection

  • Known hypersensitivity to platinum or fluoropyrimidine.
  • Pregnant or lactating woman. Women of child bearing potential not using a contraceptive method
  • Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
  • Any patients judged by the investigator to be unfit to participate in the study
  • Predicted 'non-responder' to platinum and fluoropyrimidine based on tumour expression signature derived from in- vitro sensitivity array
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01100801

Contacts
Contact: Wei Peng Yong, MRCP,MB ChB 65 6772 4670 Wei_Peng_Yong@nuhs.edu.sg

Locations
Singapore
National University Hospital Recruiting
Singapore, Singapore
Contact: Wei Peng Yong, MRCP, MB ChB    65 6772 4670    Wei_Peng_Yong@nuhs.edu.sg   
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Wei Peng Yong, MRCP, MB ChB National University Hospital, Singapore
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01100801     History of Changes
Other Study ID Numbers: GA01/01/10
Study First Received: April 7, 2010
Last Updated: January 13, 2014
Health Authority: Singapore: Domain Specific Review Boards

Additional relevant MeSH terms:
Stomach Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Oxaliplatin
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014