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Phase 2
21 Years
Open (Enrolling)
Advanced Gastric Cancer

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Trial Information

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

- Recovery from relevant toxicity to previous treatment before study entry

- Ability to understand and willingness to sign a written informed consent before study

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Wei Peng Yong, MRCP, MB ChB

Investigator Role:

Principal Investigator

Investigator Affiliation:

National University Hospital, Singapore


Singapore: Domain Specific Review Boards

Study ID:




Start Date:

July 2010

Completion Date:

Related Keywords:

  • Advanced Gastric Cancer
  • Stomach Neoplasms