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A Study of Genomic-guided 'Standard-of-care' Chemotherapy for in Advanced Gastric Cancer Patients (3G)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by National University Hospital, Singapore
Sponsor:
Collaborators:
National Cancer Centre, Singapore
Yonsei University
Information provided by (Responsible Party):
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01100801
First received: April 7, 2010
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

This is an open, non-randomized, multicenter Phase II study evaluating cisplatin plus TS-1 or oxaliplatin plus TS-1 as first-line therapy in predicted 'responder' to platinum and fluoropyrimidine.

This study is planned in 3 centers in Singapore and Korea. A total of 30 subjects will be enrolled into each treatment arms. Each centers will recruit 15-25 subjects predicted to be 'responder' to platinum and fluoropyrimidine. The study will consist of a prescreening period, a screening period and a treatment period. A fresh tumour biopsy sample will be obtained during the prescreening period for gene expression profiling.

As this is a genomics guided trial, obtaining tissue biopsies is vital to the conduct of the trial.

Patients will have the primary in situ (requirement for entry into trial), endoscopic biopsy performed prior to 1st cycle.


Condition Intervention Phase
Recurrent Gastric Cancer
Drug: TS-1 with cisplatin
Drug: TS-1 with oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Genomic-guided 'Standard-of-care' Chemotherapy for in Advanced Gastric Cancer Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Response Rate (RR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To determine the response rate of cisplatin/TS-1 and oxaliplatin/TS-1 combination in predicted 'responders'


Estimated Enrollment: 90
Study Start Date: July 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TS-1 with cisplatin

Chemotherapy injection (60mg/m2 cisplatin) will be given on day 1.

14 days of Oral TS-1 (40mg/m²) will be prescribed. Subjects will take it after breakfast and evening meal on Day 1-14 of a 3-weekly treatment cycle. Each cycle is about 21 days.

Drug: TS-1 with cisplatin
Other Name: TS-1 with cis-diamminedichloroplatinum
Experimental: TS-1 with oxaliplatin

Chemotherapy injection (100mg/m2 oxaliplatin) will be given on day 1.

14 days of Oral TS-1 (40mg/m²) will be prescribed. Subjects will take it after breakfast and evening meal on Day 1-14 of a 3-weekly treatment cycle. Each cycle is about 21 days.

Drug: TS-1 with oxaliplatin
Other Name: TS-1 with 3rd-generation platinum analog

Detailed Description:

Gastric cancer is the world's second leading cause of cancer death. For patients with unresectable disease or recurrent disease after surgery, the main therapeutic option is chemotherapy. Chemotherapy can improve survival and quality of life in patients with advanced disease when compared with best supportive care alone.

Despite a large number of randomized trials, there is no consensus as to the best agent or regimen. In general, combination chemotherapy regimens provide higher response rates than do single agent, however, this translates into only a modest improvement in outcome with a trade off in increased treatment toxicities. The key challenge in managing patients with advanced gastric cancer is to identify the appropriate drugs for patients who might benefit for palliative chemotherapy.

Gastric cancer is a heterogeneous disease with differing chemosensitivities to anti-cancer drugs. Current selection of standard therapy is often empirical. Gene expression profiling has been shown to have the capability to dissect this heterogeneity allowing for sub-classification and risk-stratification of cancers according to their biological features and clinical outcome. Utilising gene expression data coupled with in-vitro, in-vivo or clinical response data is a promising strategy that may enable clinicians to match the right drug to the right patient.

The purpose of the study are:

  1. Assess the feasibility of genomic-guided therapy
  2. Evaluated treatment response of standard-of-care chemotherapy in an enriched patient groups defined as 'responder' based on genomic-guided therapy
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
National Cancer Centre, Singapore
Yonsei University
Investigators
Principal Investigator: Wei Peng Yong, MRCP, MB ChB National University Hospital, Singapore
  More Information

Publications:
Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01100801     History of Changes
Other Study ID Numbers: GA01/01/10, 2010/00064
Study First Received: April 7, 2010
Last Updated: October 13, 2014
Health Authority: Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority

Keywords provided by National University Hospital, Singapore:
advanced
metastatic

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

ClinicalTrials.gov processed this record on November 20, 2014