|
Breast / Chinese
Herbal Medicine / Colon / Gastric
Liver / Lung / Lymphoma / NPC
/ Pancreas/ Supportive Care
/ SYM
Breast Cancer
(BRE002) A randomized trial of high-dose epirubicin
and cyclophosphamide x 3 supported by peripheral blood
projector cells versus anthracycline and cyclophosphamide
x 4 followed by cyclophosphamide, methotrexate &
5-fluorouracil as adjuvant treatment for high risk operable
stage II and stage III breast cancer in premenopausal
and young postmenopausal (<65 yrs) patients. (Collaboration
with IBCSG)
Eligibility: Premenopausal and young
postmenopausal (<65years) patients with histologically
proven, high risk operable breast cancer as defined
by the following groups: >=10 involved axillary
lymph nodes, ER negative tumors with >=5 involved
axillary lymph nodes
Objectives: To evaluate the efficacy
of 3 cycles of dose-intensive epirubicin and cyclophosphamide
supported by filgrastim-mobilised peripheral blood
progenitor cell and filgrastim in women with high
risk, operable stage II and stage III breast cancer.
The increase in total dose and dose intensity of chemotherapy
is hypothesized to increase tumor cell kill. Compare
the overall survival, Q-TWiST, QOL, systemic disease
free survival duration
Status: Follow Up
Chair: Prof. Winnie Yeo
(BRE005) A randomized double-blind trial in postmenopausal
women with primary breast cancer who had received TMV
for 2-3 years. (Sponsored by Pharmacia-Upjohn)
Eligibility: Postmenopausal women
patients who have received tamoxifen for 2 to 3 years,
histologically or cytologically proven unilateral
operable breast adenocarcinoma, after adequate therapy
for primary disease, primary tumour ER status positive
or ER unknown
Objectives: Endpoints are disease
free survival and overall survival after 5 years of
tamoxifen or in adjuvant of exemestane, the nominal
timepoint of interest is one year completion of trial
therapy (6 years after breast cancer diagnosis)
Status: Follow Up
Chair: Prof. Winnie Yeo
(BRE008) A multicenter Phase III randomized trial
comparing docetaxel in combination with doxorubincin
and cyclophosphamide (TAC) versus doxorubincin and cyclophosphamide
followed by docetaxel (AC->T)as adjuvant treatment
of operable breast cancer her2neu negative patients
with positive axillary lymph nodes-BCIRG trial. (Sponsored
by Breast Cancer International Research Group (BCIRG)/Aventis
Pharma)
Eligibility: Histologically proven
breast cancer patients within 60 days after definitive
surgical treatment with axillary lymph node dissection
for operable breast cancer (T1-3, clinical N0-1, M0),
with age 18-70. Tumor must show negative her2neu proto-oncogence
overexpression by FISH.
Objectives: To compare disease-free
survival after treatment. To compare overall survival,
toxicity and quality of life between arms. To evaluate
pathologic and molecular markers for predicting efficacy.
Status: Follow Up
Chair: Prof. Winnie Yeo
(BRE015) Open-label study of bevacizumab(AVASTIN®)plus
taxane monotherapy or in combination for the first-line
treatment of patients with locally recurrent or metastatic
breast cancer –ATHENA study (Sponsored by F.Hoffmann-La
Roche LTD)
Eligibility: Patient who is confirmed
with local recurrent or metastatic disease and who
are candidates for chemotherapy. Locally recurrent
disease must not be amenable to radiation therapy
or resection with curative intent. Patient should
have adequate hematological function, liver and renal
functions.
Objectives: To assess the efficacy
of bevacizumab when combined with taxane monotherapy
or in combination as first line treatment of patients
with local recurrent or metastatic breast cancer as
measured by time to disease progression and overall
survival.
Status: Active
Chair: Dr WM Ho
(BRE017) An Open-Label Multicenter Study Administering
Lapatinib and Capecitabine (Xeloda) in Women with Advanced
or Metastatic Breast Cancer
Eligibility: Female = 18 years old.
Histologically confirmed invasive breast cancer with
stage IIIb/c or stage IV disease; with documented
overexpression of Her2 (ErbB2) of IHC 3+ or FISH positive
in primary or metastatic tumor tissue. Patient must
have prior therapies including at minimum a taxane
and/or anthracyclines and may include trastuzumab
if available. Patient also should have reasonable
hematologic, hepatic and renal function.
Objectives: To evaluate overall clinical
benefit response rate (i.e., CR or PR or SD for at
least 24 weeks)
Status: Active
Chair: Prof Winnie Yeo
Colon Cancer
(COL008) Open, randomized, controlled, multicenter
phase III study comparing 5-FU/FA plus irinotecan plus
cetuximab versus 5-FU/FA plus irinotecan as first-line
treatment for epidermal growth factor receptor-expressing
metastatic colorectal carcinoma (CRYSTAL study) (Sponsored
by Merck KGaA)
Eligibility: Patient with histologically
documented colorectal cancer with is EGFR-positive,
age 18 years or over, inoperable metastatic disease
with ECOG performance status of 0-2 at study entry
and with reasonable hematology, liver and renal functions.
Objectives: To assess whether the
progression-free survival (PFS) time under 5-FU/FA
plus irinotecan plus cetuximab is longer than that
under 5-FU/FA plus irinotecan as first-line treatment
for EGFR-expressing metastatic CRC.
Status: Follow Up
Chair: Prof. Anthony Chan
(COL009) A Randomized, Three Arm Multinational Phase
III Study to Investigate Bevacizumab (q3w or q2w) in
Combination With Either Intermittent Capecitabine Plus
Oxaliplatin (XELOX) (q3w) or Fluorouracil/Leucovorin
With Oxaliplatin (FOLFOX-4) Versus FOLFOX-4 Regimen
Alone as Adjuvant Chemotherapy in Colon Carcinoma
(The AVANT Study) (Sponsored by F HOFFMANN-LA ROCHE
AG)
Eligibility: Male and female outpatients
18 years of age or over with histological confirmed
colon carcinoma who have had potentially curative
surgery not less than 4 and not more than 8 weeks
prior to randomization. Patient must not have previous
treatment for any malignancy. Patient must have ECOG
performance status 0 or 1 with no evidence of remaining
tumor.
Objectives: 1) To demonstrate that
the combination of bevacizumab and FOLFOX-4 is superior
to FOLFOX-4 alone in terms of disease-free survival
in chemotherapy-naïve patients who underwent
surgery with curative intent for colon carcinoma.
2) To demonstrate that the combination of bevacizumab
and XELOX is superior to FOLFOX-4 alone in terms of
disease-free survival in chemotherapy-na?ve patients
who underwent surgery with curative intent for colon
carcinoma.
Status: Follow Up
Chair: Prof. Anthony Chan
Gastric
Cancer
(GAT007) A double-blind, randomised, multicenter,
phase III study of bevacizumab in combination with capecitabine
and cisplatin versus placebo in combination with capecitabine
and cisplatin, as first-line therapy in patients with
advanced gastric cancer
Eligibility: Written Informed Consent
/ >18 years / Compliance. ECOG 0,1,2 / Life expectancy
> 3 months. Histologically confirmed adenocarcinoma
of stomach or gastro-oesophageal junction (advanced/metastatic/inoperable).
Measurable or non-measurable disease (according to
RECIST)
Objectives:Primary objective:Overall
survival. Secondary objectives:Progression-free survival.
Progression free survival during first line therapy.
Time to progression. Overall response rate. Duration
of response during first line therapy.
Disease control rate in two treatment groups. Safety
profile in the two treatment groups.
Status: Active
Chair: Dr Lam, Kwok Chi
Liver Cancer
(HCC016) A Phase 3 Randomized Study to Evaluate Survival
of Patients Treated with Talaporfin Sodium (LS11) and
Interstitial Light Emitting Diodes (LED) as Compared
to the Standard of Care Therapies in the Treatment of
Unresectable Hepatocellular Carcinoma (HCC) (Sponsored
by Light Sciences Oncology)
Eligibility: Histologically evidence
of HCC or two different imaging techniques with characteristics
that suggest HCC or combination of one imaging technique
that suggests HCC and serum AFP level >400ng/mL.
Patient must have less than 6 lesions and the disease
are not for complete surgical resection. Moreover,
patient should be with ECOG =2 and adequate haematologic,
renal and hepatic function.
Objectives: To assess the survival
of a subset of patients in the Litx group who received
Litx treatment followed by the standard of care versus
patients in the standard of care group for the treatment
of unresectable hepatocellular carcinoma (HCC).
Status: Active
Chair: Prof. Tony Mok
(HCC017) A Randomized Controlled Trial of Transarterial
Ethanol Ablation (TEA) with Lipiodol-Ethanol Mixture
(LEM) versus Transcatheter Arterial Chemoembolisation
(TACE) for Unresectable Hepatocellular Carcinoma (HCC).
Eligibility: Histologically or cytologically
proven unresectable HCC; massive expansive tumor type
with measurable lesion on CT scan with reasonable
tumor size. Patient should also have good performance
status and acceptable liver and renal functions.
Objectives: To evaluate survival
(overall and progression free survival) of patients
with localized unresectable HCC treated with TEA with
LEM as compared to TACE.
Status: Active
Chair: Dr. Simon Yu, Prof. Winnie
Yeo
Lung Cancer
(LUN019) An expanded access program of Tarceva in
patients with advanced stage IIIb/IV non-small cell
lung cancer
Eligibility: Age >18 years. Histologically
or cytologically documented inoperable, locally advanced
stage IIIb, metastatic stage IV, ECOG 0-3, No more
than 2 prior chemotherapy regimens are permissible.
Objectives: Primary: To provide Tarceva
to patients with advanced stage IIIb/IV NSCLC who
have received at least one course of standard systemic
chemotherapy or radiation therapy or who are in the
investigator’s opinion not medically suitable
for chemotherapy or radiotherapy. Secondary: To evaluate
the response rate, time to progression, safety, survival.
Status: Active
Chair: Prof. Tony Mok
(LUN021) An open label, randomized, parallel group,
multicentre, phase III study to assess efficacy, safety
and tolerability of Gefitinib versus carboplatin/paclitaxel
doublet chemotherapy as first-line treatment in selected
patients with advanced stage IIIb or IV NSCLC in Asia
(Sponsored by AstraZeneca group of companies)
Eligibility:Histological proven
stage III or IV non-small cell lung cancer (with adenocarcinoma
histology) patients with age >=18 years and must
have no prior chemotherapy for advanced NSCLC.
Objectives: To compare gefitinib
with carboplatin/placlitaxel doublet chemotherapy
given as first line treatment in terms of progression
free survival
To compare the randomized treatment arms in terms
of overall survival.
To compare gefitinib with carboplatin/placlitaxel
doublet chemotherapy given as first line treatment
in terms of objective response rate.
Status: Follow Up
Chair: Prof. Tony Mok
(LUN025) A Phase III, International, randomised, double-blind,
parallel-group, multi-centre study to assess the efficacy
of ZD6474 versus erlotinib in patients with locally
advanced or metastatic (stage IIIB-IV) NSCLC after failure
of at least one prior chemotherapy ( Zactima study 57)
(Sponsored by AstraZeneca)
Eligibility:Histological proven
locally advanced or metastatic NSCLC patients with
age ³18 years and had failure of at least one,
but no more than two, prior cytotoxic chemotherapy
regimens.
Objectives: Overall survival for ZD6474 compared
with Erlotinib. Demonstrate an improvement in the
time-to-deterioration of pain, dyspnea, cough in patients
treated with ZD6474. Study the safety and tolerability
of ZD6474 compared with Erlotinib.
Status: Follow Up
Chair: Prof. Tony Mok
(LUN026) Open label study of AVASTIN® (bevacizumab)
in combination with platinum containing chemotherapy
as first line treatment of patients with advanced or
recurrent non-squamous non-small cell lung cancer
(SAIL – Safety of Avastin In Lung)
Eligibility: Patients with age ³18
years. Histological proven locally advanced or metastatic
NSCLC other than squamous cell and had no prior palliative
chemotherapy.
Objectives: To assess the safety profile
of Avastin when combined with chemotherapy as 1st
line treatment of advanced or recurrent non-squamous
NSCLC.
To assess the efficacy of Avastin as measured by time
to disease progression and overall survival.
To assess the safety of Avastin in patients who develop
CNS metastases during and for 6 months following the
treatment period.
Status: Active
Chair: Prof. Tony Mok
(LUN027) A multi-center phase III randomized, double-blind
placebo-controlled study of the cancer vaccine Stimuvax
(L-BLP25 or BLP25 liposome vaccine) in non-small cell
lung cancer (NSCLC) subjects with unresectable stage
III disease (START Study)
Eligibility: Patients with age ³18
years.Histological proven stage III NSCLC and achieved
stable disease or objective response after primary
chemo-radiotherapy.
Objectives: To compare survival duration
of all randomized subjects by treatment arm. TTSP
is as measured by LCSS and as determined by the investigator.
One-, two-, three-year survival and safety.
Status: Active
Chair: Prof. Tony Mok
(LUN028) A phase III, International, Randomised, Double-Blind,
Parallel-Group, Multi-Centre to Assess the Efficacy
of ZD6474 (ZACTIMA) Plus Best Supportive care Versus
Placebo Plus Best Supportive Care in Patients With Locally
Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell
Lung Cancer (NSCLC) after Prior Therapy with an Epidermal
Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR
TKI)
Eligibility: Female or male with
age ³18 years. Histologic or cytologic confirmation
of locally advanced or metastatic NSCLC (IIIB-IV)
on entry into study. Failure of prior therapy (during
or after treatment) with an EGFR tyrosine kinase inhibitor
(e.g. erlotinib or gefitinib either radiological documentation
of disease progression or due to toxocity). At least
one but no more than two prior chemotherapy regimens.
Objectives: To demonstrate an improvement
in overall survival for ZD6474 plus best supportive
care (BSC) compared with placebo plus BSC in patients
with locally advanced or metastatic NSCLC after prior
therapy with an EGFR TKI.
Status: Active
Chair: Prof. Tony Mok
(LUN031) A double-blind, randomized, placebo-controlled
Phase III study to assess the efficacy of recMAGE-A3
+ AS15 Antigen Specific Cancer Immunotherapeutic as
adjuvant therapy in patients with resectable MAGE-A3-positive
Non-Small Cell Lung cancer
Eligibility: Patient with completely
resected, pathologically proven stage IB, II or IIIA
NSCLC. Written informed consents prior to protocol-specific
procedures. Patient is >=18 years. MAGE-A3 positive
patient’s tumor. Surgery for tumor resection
is anatomical, involving at least a lobectomy or a
sleeve lobectomy. Mediastinal lymph node sampling
is done according to study protocol guidelines.
Objectives: Primary Objectives: Clinical
efficacy of recMAGE-A3 + AS15 versus placebo. Objective
A: Efficacy in the overall population (CT and no-CT);
Objective B: Efficacy in the no-CT population. Secondary
Objectives: Other clinical and biological indicators
of safety and efficacy. Translational research: gene
expression profile, biomarkers. Status:
Active
Chair: Prof. Tony Mok
(LUN033) A Multicenter, Randomized, DB, Controlled
Phase 3, Efficacy & Safety Study of Sunitinib (SU011248)
in Patients with Advanced/Metastatic Non-Small Cell
Lung Cancer Treated with Erlotinib (Pfizer)
Eligibility:Patient with age >=18
years old.Histological or cytological confirmation
of NSCLC and had prior treatment with 1 or 2 chemotherapy
regimens for advanced disease.
Objectives: Primary: Overall Survival (OS).Secondary:
Progression Free Survival (PFS), Objective Response
Rate (ORR).Duration of Response (DR), 1-year Survival,
Type, incidence, severity, timing, seriousness, and
relatedness of AE and lab abnormalities, EQ-5D
Status: Active
Chair: Prof. Tony Mok
Nasopharyngeal Carcinoma
(NPC006) Impact on Salivary gland Function by Intensity-Modulated
Radiation Therapy in the treatment of nasopharynx cancer:
A Prospective Randomized Trial
Eligibility: Patients with histologically
proven of NPC, and have treatment-naïve NPC.
No evidence of distant metastasis. Staging: T1/T2a/T2b
(unilateral parapharyngeal disease) and N0/N1/N2 (excluded
bilateral level I/II nodal involvement). ECOG grade
0 - 1.
Objectives: To compare the rates
of delayed xerostomia in early-stage nasopharynz cancer
patients treated by either Intensity-Modulated radiation
therapy or conventional radiation therapy.
Status: Follow-up
Chair: Prof. SF Leung, Dr. Michael
KM Kam
(NPC017) A multi-center prospective randomized phase
III trial to determine the benefit of adjuvant chemotherapy
using gemcitabine and cisplatin in nasopharyngeal carcinoma
patients with residual EBV DNA following primary radiotherapy
with or without concurrent cisplatin (NPC-0502 Trial)
Eligibility: Have given written
informed consent, prior to pre-study screening, with
the understanding that consent may be withdrawn at
any time without prejudice. A histological diagnosis
of NPC must have been established at some time and
the investigator must review and confirm the diagnosis
prior to randomization. Loco-regional advanced NPC
UICC/AJCC Stages IIB, III, IVA or IVB. No evidence
of distant metastases in the staging work up at diagnosis.
Must have detectable plasma EBV-DNA (> 0 copies/ml)
at 6-8 weeks after completion of primary RT or chemo-RT.
No clinical evidence of persistent loco-regional disease
after primary treatment. Performance status of ECOG
grade 0 or 1. Patients must have adequate organ and
marrow function as defined below: leukocytes >=
3,000/L; absolute neutrophil count >= 1,500/L;
platelets >= 100,000/L; total bilirubin <= 1.5
X institutional upper limit of normal; AST(SGOT) /
ALT(SGPT) <= 2.5 X institutional upper limit of
normal; Creatinine clearance >=50 ml/min
Objectives: To study the benefit
of adjuvant chemotherapy using gemcitabine and cisplatin
in nasopharyngeal carcinoma (NPC) patients with elevated
plasma EBV DNA following primary radiotherapy with
or without concurrent cisplatin.
Status: Active
Chair: Prof. Anthony Chan
(NPC018) Randomized trial to evaluate the therapeutic
gain by changing the chemoradiotherapy from concurrent-adjuvant
to induction-concurrent sequence, and the radiotherapy
from conventional to accelerated fractionation for advanced
nasopharyngeal carcinoma. (NPC-0501 Trial)
Eligibility: Histologically proven
nasopharyngeal carcinoma for primary treatment with
radical intent. Non-keratinizing or undifferentiated
type (i.e. exclude WHO Type I squamous cell carcinoma
or adenocarcinoma). Stage III-IVB (by AJCC/UICC 6th
edition). Age > 18 to < 70 years. Satisfactory
performance status: < 2 by ECOG System. Adequate
marrow& renal function. No pregnancy or lactation
for females of reproductive age. No Prior malignancy
except adequately treated basal cell or squamous cell
skin cancer, in-situ cervical cancer, or other cancer
for which the patient has been disease-free for 5
years. No history of previous RT (except for non-melanomatous
skin cancers outside intended RT treatment volume).
No Prior chemotherapy or surgery (except diagnostic)
to primary tumor or nodes
Objectives: The objective of this
study is to further improve the therapeutic gain of
concurrent chemoradiotherapy (CRT) for Stage III-IVB
nasopharyngeal carcinoma (NPC). All treatment arms
use Cisplatin in concurrence with radiotherapy as
the core treatment. Primary objectives include
• Comparing induction chemotherapy with Cisplatin
+ 5-Fluorouracil versus adjuvant chemotherapy with
Cisplatin + 5-Fluorouracil (PF-P vs P-PF);
• Comparing induction chemotherapy with Cisplatin
+ Capecitabine versus adjuvant chemotherapy with Cisplatin
+ 5-Fluorouracil (PX-P vs P-PF);
• Comparing accelerated fractionation versus
conventional fractionation (AF vs CF).
Secondary objectives include
• Comparing induction chemotherapy with Cisplatin
+ Capecitabine versus induction chemotherapy with
Cisplatin + 5-Fluorouracil (PF-P vs PX-P)
Status: Active
Chair: Prof. Anthony Chan
Pancreas
(PAN002)A Randomized, Double-Blind Phase 3 Study of
Gemcitabine Plus AG-013736 versus Gemcitabine Plus Placebo
for the First-Line Treatment of Patients with Locally
Advanced, Unresectable or Metastatic Pancreatic Cancer
Eligibility:Histologically or cytologically
confirmed, metastatic or locally, advanced pancreatic
adenocarcinoma not amenable to curative resection.
Patient is with good liver and renal function, adequate
bone marrow function, age > or = 18 years old.
Patient should not have prior systemic chemotherapy
for metastatic disease.
Objectives: To compare the overall
survival (OS) of patients receiving gemcitabine plus
AG-013736 versus gemcitabine plus placebo.
Status: Active
Chair: Prof. Brigette Ma
Symptom Control
Study
(SYM006) A Randomized, Double-Blind, Parallel-Group
Study Conducted Under In-House Blinding Conditions to
Determine the Efficacy and Tolerability of Aprepitant
for the Prevention of Chemotherapy-Induced Nausea and
Vomiting Associated With Moderately Emetogenic Chemotherapy
Eligibility:Patient is female or
male, and age is ³18 years. Patient has a histologically
or cytologically confirmed malignant disease. Note:
The number of breast cancer patients will be limited
to approximately 50% of the total enrollment. Patient
is naive to moderate or highly emetogenic chemotherapy.
Treated with one of the following MEC agents: Oxaliplatin,
Cytarabine > 1 g/m2, Carboplatin, Cyclophosphamide
< 1500 mg/m2, Ifosfamide, Doxorubicin, Daunorubicin,
Epirubicin, Idarubicin, Irinotecan.
Objectives: (1) To compare the Aprepitant
Regimen and the Control Regimen with
respect to efficacy in the first cycle of MEC. (2)
To evaluate the safety and tolerability of
the Aprepitant Regimen for CINV.
Status: Active
Chair: Prof. Winne Yeo
|
