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

This study is currently recruiting participants. (see Contacts and Locations)
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
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: 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 July 10, 2014