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HER 2 Positive Advanced Gastric CancerPhase 2NCT01736410

A Phase 2 Study of Trastuzumab in Combination With TS-ONE and Cisplatin in Firstline Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer

A Phase 2 study testing Trastuzumab, TS ONE, Cisplatin in people with HER 2 Positive Advanced Gastric Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To explore overall response rate of trastuzumab combined with TS-ONE based chemotherapy in first-line HER2-positive advanced gastric cancer. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
HER 2 Positive Advanced Gastric Cancer
What is being tested?
Trastuzumab, TS ONE, Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSingapore
Study dates
May 2010to May 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach and Gastric-esophageal junction.
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as more than or equals to 20 mm with conventional techniques or as more than or equals to 10 mm with spiral CT scan.
  • Patients without prior systemic treatment. Patients who completed postoperative adjuvant chemotherapy (and radiotherapy) more than 180 days before may be enrolled.
  • Age more than or equals to 21 years.
  • Life expectancy of greater than 3 months.
  • ECOG performance status less than or equals to 2 (Karnofsky more than or equals to 60%).
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  • Patients must have normal organ and marrow function as defined below:
  • Hemoglobin > 8.0 g/dL
  • Leukocytes > 3,000/mcL
  • Absolute neutrophil count > 1,500/mcL
  • Platelets > 100,000/mcL
  • Total bilirubin less than or equals to 1.5 X ULN
  • AST (SGOT)/ALT (SGPT) less than or equals to 3 x institutional upper limit of normal
  • ALP less than or equals to 3 x upper limit of normal*
  • Creatinine within normal institutional limits OR Creatinine clearance** >60 mL/min for patients with creatinine levels above institutional normal
  • In the presence of liver metastasis, patients with AST, ALT and ALP < or = 5 x the upper limit of normal may be admitted. *In the presence of bone metastasis, patients with AST ,ALT and ALP < or = 10x the upper limit of normal maybe admitted. **: Creatinine clearance can be estimated using Cockcroft-Gault formula man: Ccr (mL/min) = body weight (kg) x (140 - age)/(72 x serum creatinine (mg/dL)), woman: Ccr = male Ccr x 0.85]. The above CrCl Formula is to be applied in all sites.
  • Patients who have HER2-positive cancer confirmed with IHC and/or FISH***.
  • Immunohistochemistry (IHC) for HER-2 is routine as part of pathological evaluation of gastric hybridisation (FISH) for Her2 copy number is required. A copy number value above 2.2 is taken as positive. The sponsors for the drugs used in our investigator initiated trial (Taiho) have kindly agreed to pay for the HER2 FISH test.
  • Patients able to take orally.
  • Patients with left ventricular ejection fraction of at least 50% on MUGA or 2D-echocardiography done within 28 days before enrollment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • The effects of proposed regimen on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because antitumor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Consent for fresh frozen tissue collection, mandatory for patients with primary in-situ tumors and optional for patients without primary in-situ tumors.
  • Tissue collection only applicable to National Cancer Centre (S) and National University Hospital (S)

Who cannot join

  • Patients who have had radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to treatment administered more than 4 weeks earlier.
  • Patients receiving any other investigational agents.
  • Patients with known brain metastases.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to TS-ONE, cisplatin and trastuzumab or other agents used in the study.
  • Presence of any contraindications to TS-ONE or cisplatin or trastuzumab.
  • Baseline LVEF (Left Ventricular Ejection Fraction) < 50%.
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  • Patients with serious (e.g.inpatient care is needed) complications (e.g. intestinal paralysis, intestinal occlusion, interstitial pneumonia or pulmonary fibrosis, poorly-controlled diabetes, renal failure or hepatic cirrhosis).
  • Patients with massive ascites (moderate or higher, beyond the pelvic cavity and retention on the anterior surface of the liver on CT) or massive pleural effusion retention.
  • Patients with fresh bleeding from the digestive tract which needs repeated blood transfusion.
  • Patients with diarrhea (4 or more times per day or watery diarrhea).
  • Previous malignancy other than gastric cancer diagnosed in the last 5 years except for basal cell carcinoma of skin or preinvasive cancer of cervix.
  • Patients with reproductive potential who refuse to use an adequate means of contraception (including male patients).
  • Significant disease or conditions which, in the investigator's opinion, would exclude patient from the study.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant or lactating female.
  • HIV-positive patients.

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • National Cancer Centre Singapore

    Singapore, Singapore, 169610

Other trials in Singapore

About this study

To explore overall response rate of trastuzumab combined with TS-ONE based chemotherapy in first-line HER2-positive advanced gastric cancer.

Being tested
Trastuzumab, TS ONE, Cisplatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trastuzumab, TS ONE, CisplatinDrug

    The initial dose of cisplatin is fixed to be 60 mg/m2 and intravenously administered over 1 hour on day 1 of the cycle. TS-ONE is orally administered consecutive 14-day followed by 7-day rest. The initial standard dose of TS-ONE is determined based on the body surface area tabled below. Trastuzumab is intravenously administered with the loading dose of 8 mg/kg followed by HER2-positive advanced GC 21 years or older No prior regimen HER2 protein HER2/neu detection procedure Tissue from (Gastric) Cancer FISH method IHC method negative positive HER-2 negative HER-2 positive Eligible 0 / 1+ 2+ 3+ HER-2 positive Eligible HER-2 negative iii Protocol S1/CDDP/Her V1.3 dated 21 May 10 maintenance dose of 6mg/kg in day 1 of each cycle. The study treatments are repeated every 3 weeks. Study treatment can continue until PD, but cisplatin can be skipped or discontinued if patients experienced unbearable toxicity which comes from cisplatin.

Study groups in NCT01736410
Study groupRoleWhat they receive
IHC methodOtherNot described
Receives: Drug: Trastuzumab, TS ONE, Cisplatin
FISH methodOtherNot described
Receives: Drug: Trastuzumab, TS ONE, Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    Measured: 24 months

Secondary outcomes (3)

  1. Progression free survival (PFS)

    Measured: 24 months

  2. Overall survival (OS)

    Measured: 24 months

  3. Time to Treatment Failure (TTF)

    Clinical Benefit Rate (CBR), Duration of Response (DR), Safety

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2012 (estimated)
  2. Study startMay 2010
  3. Primary completionApr 2013
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01736410
Sponsor's protocol ID
NCC0906
Status last verified
Jun 2013
First submitted
26 Nov 2012
Last updated
17 Jun 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab, TS ONE, Cisplatin in people with HER 2 Positive Advanced Gastric Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01736410.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2013.

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