| Selected Publications |
Leong SS, Wee J, Rajan S, Toh CK, Lim WT, Hee SW, Tay MH, Poon D, Tan EH Triplet combination of gemcitabine, paclitaxel and carboplatin followed by maintenance 5-fluorouracil and folinic acid in patients with metastatic nasopharygeal carcinoma.
Cancer (2008) 113:1332-1337.
Wee J, Tan EH, Tai BC, Wong HB, Leong SS, Tan T, Chua ET, Yang ETL, Lee KM, Fong KW, Khoo-Tan HS, Lee KS, Loong SL, Sethi VJ, Chua EJ, Machin D Randomised phase III trial of radiotherapy versus concurrent chemo-radiotherapy followed by adjuvant chemotherapy in patients with AJCC/UICC (1997) stage III and IV nasopharyngeal cancer of the endemic variety.
J Clin Oncol (2005) 23(27):6730-6738.
Wong ZW, Ang PC, Chowbay B, Wong NS, See HT, Khoo KS
Phase I / II trial of gemcitabine with pegylated liposomal doxorubicin as first-line therapy in Asian women with metastatic breast cancer.
Breast (2008) Oct 17(5):517-22.
Ma B, Goh BC, Tan EH, Lam KC, Soo R, Leong SS, Wang LZ, Mo F, Chan AT, Zee B, Mok T
A multicenter phase II trial of 3-aminopyridine-2-carboxaldehyde thiosemicarbazone (3-AP, Triapine) and gemcitabine in advanced non-small-cell lung cancer with pharmacokinetic evaluation using peripheral blood mononuclear cells.
Invest New Drugs (2008) 26:169-173.
Tan EH, Rolski J, Grodzki T, Schneider CP, Gatzemeier U, Zatloukal P, Aitini E, Carteni G, Riska H, Tsai YH, Abratt R
Global Lung Oncology Branch trial 3 (GLOB3): final results of a randomised multinational phase III study alternating oral and IV vinorelbine plus cisplatin versus docetaxel plus cisplatin as first-line treatment for advanced non-small cell lung cancer.
Ann Oncol (2009) 20(7):1249-1256 .
Loong SL, Hwang JS, li HH, Wee JT et al
Negligible or weak expression of cyclooxygenase-2 is associated with poorer outcome in endemic nasopharyngeal carcinoma: analysis of data from randomised trial between radiation alone versus concurrent chemo-radiation (SQNP-01).
Radiat Oncol. 2009 Jul 10;4(1):23 (Epub ahead of print).
LIM WT, Tan EH, Toh CK, Hee SW, Leong SS, Ang PCS, Wong NS, Chowbay B
Phase I pharmacokinetic study of a weekly liposomal paclitaxel formulation (Genexol-PM) in patients with solid tumors.
Ann Oncol 2009 Jul 24 (Epub ahead of print).
Leong SS, Fong KW, Lim WT, Toh CK, Yap SP, Hee SW, Tan EH
A phase II study of induction gencitabine and vinorelbine followed by concurrent vinorelbine and radiotherapy in locally advancednon-small cell lung cancer.
Lung Cancer 2009 (Epub ahead of print).
Wang A, Lal S, Sandanaraj E, Lim WT, Leong SS, Tan EH, Chowbay B
Phase I dose finding study of Genexel-PM in Asian cancer patients.
J Clin Oncol 2008 26:621s (Abstr 13512).
Yap SP, Lim WT, Foo KF, Hee SW, Leong SSm Fong KW, Eng P, Hsu, AA, Wee JTS, Agasthian T, Koong HN, Tan EH
Induction concurrent chemoradiotherapy using Paclitaxel and Carboplatin combination followed by surgery in locoregionally advanced NSCLC – Asian experience.
Ann Acad Med Singapore 2008 37:377-6.
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Cancer is a major health problem worldwide. About 10 million people annually are diagnosed with this disease and six million are expected to die from it. In Singapore the crude cancer incidence rate is expected to rise for the next two decades as the baby boomers now reach the age when most cancers develop. Unfortunately, despite the best efforts, we are still unable to cure most patients with recurrent cancer. Hence, search for new therapies, is critical for the cure of cancer, for the prolongation and the improvement of quality of life. These therapies are developed through clinical trials, which involve regulated and closely-monitored processes of testing new drugs and drug combinations in humans, so as to evaluate and confirm their efficacy and safety. The Clinical Trials Office of the Humphrey Oei Institute of Cancer Research provides the infra-structural support for the conduct of all phases of clinical trials at the National Cancer Centre Singapore.
We have a team of dedicated staff to support investigators in areas such as trial co-ordination, budget and project planning, protocol development, negotiations of agreements, ethical and regulatory submissions, case report form designs and data discrepancy management.
Research Experience
We have more than 16 years of experience in conducting clinical trials and to date, have completed over a hundred clinical trials involving close to 2,300 subjects in total. Currently we have about 100 ongoing trials. Of particular interests are trials of the new small molecular targeted agents, vaccines, stem-cell mini-transplants and adoptive T cell therapies on the different cancers types such as breast, lung, nasopharynx, stomach, colorectum and liver cancers.
Our investigators are constantly in search of new methods and treatments and are actively coming up with new ideas and protocols for clinical testing. We have completed a total of 46 investigator-initiated trials (IITs) and there are currently 37 which are ongoing and another 13 which will start within the year. Our IITs span the range from Phase I to III. We also have a number of investigators who are very experienced in collaborating with the pharmaceutical industries to conduct industry drug development trials. Most of our investigators put aside time to run special trial clinics, in order to give ample time and attention to each of our trial subjects.
Our Infrastructure
The National Cancer Centre Singapore has always supported its Institutional Review Board’s (IRB) commitment to protect human research subjects. Its IRB has obtained certification from the United States Department of Health and Human Services in the Federal wide Assurance program for human protection. This certification allows NCCS to qualify for US Government supported research from CTEP of the US National Cancer Institute. This role has since been taken over by the SingHealth Centralised IRB which supports review of human research for all SingHealth institutions.
Our research co-ordinators (CRC) are stringently selected to ensure that they have the aptitude, qualification and interests suitable for the work. Most of our co-ordinators have at least a degree in medicine, nursing, life or health sciences. The CRCs take care of most of the routine tasks associated with the conduct of trials, such as assisting the investigators in logistical and administrative tasks, in study initiation, patient recruitment, trial conduct and data collection. The co-ordinators are required to constantly upgrade their knowledge by attending continuous education programmes and advanced training to remain competitive. Newly recruited co-ordinators have to undergo rigorous training which includes the in-house training programme, training in GCP, CITI course certification for the protection of human research subjects and on-the-job training as apprentice for six months under strict supervision of the team leaders and other qualified staff.
We are well-equipped to carry out routine trial procedures. In the Clinical Trials Office and in the clinics, our co-ordinators have access to online systems for information on patient investigation results, appointments and treatment. Patient information sheets and eligibility criteria are also available online for the convenience of investigators. We also have the facilities and knowledge to ensure that biological specimens for central laboratories are handled under the protocol prescribed conditions. NCCS also has a GMP laboratory for preparing some of our biological agents.
We work very closely with various departments at the National Cancer Centre Singapore, such as Pharmacy, Ambulatory Care Unit, Oncologic Imaging Department and the clinical departments as well as other departments within the campus such as Singapore General Hospital’s Pathology Department and the SingHealth’s Investigational Medicine Unit. Our trial drugs are stored in optimal conditions in the pharmacy. Dispensing, reconstitution and drug accountability are performed by registered oncology pharmacist. We also have a dedicated Clinical Trial Pharmacist. The Ambulatory Care Unit nurses play an active role as part of the study team to ensure that the administration and handling of study drugs are performed according to the protocol. The Oncologic Imaging Department ensures that imaging requirements for trials are met and their radiologists provide image consultation service for trials upon request. In addition, our radiologists are also involved in research areas such as DCE-CT and DCE-MRI. PET and SPECT are available in Outram Campus, and the Nuclear Medicine Department has its own in-house radio-chemist. We use the services of the Singapore General Hospital’s Pathology Department, which is accredited by The College of American Pathologists and the Joint Commission International and certified by T Ü V S Ü D PSB Certification Pte Ltd. We also work closely with the Singhealth Investigational Medicine Unit, which has a 30-bed in-patient unit for early phase trials.
We use the Oracle Clinical Data Management System to manage data for our IITs. Our data management team, which includes a trained system analyst and data management co-ordinators; works closely with our statisticians, co-ordinators and investigators in supporting our IITs.
We have specific Standard Operating Procedures to help us achieve consistency and to maintain a high standard in clinical trial management, particularly in areas such as patient randomisation, coordination procedures, blood processing and delivery, data management, ethics and regulatory requirements, safety reporting and financial management.
Future Direction
We aim to continue to act as the central liaison to provide a centralised service for site feasibility studies, in trial budget and agreement negotiation and in trial coordination and data management for the National Cancer Centre Singapore. We also aim to expand and extend our services to collaborate with more of our pharmaceutical partners as well as to link up with the major academic trial groups. We will continue to provide strong support to our doctors for both industry and investigator-initiated trials. |
