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Gastric CancerPhase 2NCT01364493

A Study to Evaluate the Efficacy and Safety of Trastuzumab in Combination With Capecitabine and Oxaliplatin as First-line Chemotherapy for Inoperable, Locally Advanced or Recurrent and/or Metastatic Gastric Cancer

A Phase 2 study testing Trastuzumab+Capecitabine+Oxaliplatin in people with Gastric Cancer, run by Peking University at 1 site in China.

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

Although the overall incidence of gastric cancer has steadily declined in many Western countries during the last few decades, it is still one of the most common tumors in China. It is now well recognised that combination chemotherapy regimens improve patient outcomes, but there is no accepted global standard regimen… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Trastuzumab+Capecitabine+Oxaliplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteChina
Study dates
May 2011to Feb 2014
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy.
  • Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.0), assessed using imaging techniques (CT or MRI).
  • HER2 positive tumour (primary tumour or metastasis) as assessed by the central laboratory. (Both IHC and Dual SISH will be performed on all patients in the central laboratory.)
  • ECOG Performance status 0, 1 or 2.
  • Life expectancy of at least 3 months.
  • Male or female. Age ≥ 18 years.
  • Signed informed consent.

Who cannot join

  • Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study; the total dose of cisplatin should be less than 300mg/m2, adjuvant/neoadjuvant therapy with oxaplatin is not allowed).
  • No prior use of EGFR-targeting drugs,such as Trastuzumab,lapatinib or other TKIs.
  • Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy probe).
  • Patients with active (significant or uncontrolled) gastrointestinal bleeding.
  • Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity ≥ grade 2 NCI-CTCAE 4.0.
  • Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
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  • Neutrophil count < 1.5 × 109/L, or hemoglobin < 90 g/L,or platelet count < 100 × 109/L.
  • Serum bilirubin > 1.5 × upper limit of normal (ULN); or, AST or ALT > 2.5 × ULN(or > 5 × ULN in patients with liver metastases); or, alkaline phosphatase > 2.5 × ULN (or > 5 × ULN in patients with liver metastases, or > 10 × ULN in patients with bone but no liver metastases); or, albumin < 25 g/L.
  • Creatinine clearance < 60 mL/min.
  • History of documented congestive heart failure; angina pectoris requiring medication;evidence of transmural myocardial infarction on ECG; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias.
  • Baseline LVEF < 50% (measured by echocardiography or MUGA).
  • Patients with dyspnoea at rest due to complications of advanced malignancy or other disease, or who require supportive oxygen therapy.
  • Patients receiving chronic or high dose corticosteroid therapy. (Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed).
  • Clinically significant hearing abnormality.
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency.
  • History or clinical evidence of brain metastases.
  • Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.
  • Positive serum pregnancy test in women of childbearing potential.
  • Subjects with reproductive potential not willing to use an effective method of contraception.
  • Received any investigational drug treatment within 4 weeks of start of study treatment.
  • Radiotherapy within 4 weeks of start of study treatment (2 week interval allowed if palliative radiotherapy given to bone metastastic site peripherally and patient recovered from any acute toxicity;prior adjuvant radiotherapy is allowed if complete at least 6 months ).
  • Major surgery within 4 weeks of start of study treatment, without complete recovery.
  • Patients with known active infection with HIV, HBV, or HCV.
  • Known hypersensitivity to any of the study drugs.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Lin Shen

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

Official title: An Open-label, Single Arm Study to Evaluate the Efficacy and Safety of Trastuzumab in Combination With Capecitabine and Oxaliplatin (XELOX) as a First-line Chemotherapy for Inoperable, Locally Advanced or Recurrent and/or Metastatic Gastric Cancer

Although the overall incidence of gastric cancer has steadily declined in many Western countries during the last few decades, it is still one of the most common tumors in China. It is now well recognised that combination chemotherapy regimens improve patient outcomes, but there is no accepted global standard regimen for advanced gastric cancer.

The ToGA study was the first randomized, prospective, multicenter, phase III trial to show the efficacy and safety of Trastuzumab in HER2- positive GC. Trastuzumab reduced the risk of death by 26% (HR 0.74; 95% CI 0∙60, 0∙91; p=0∙0046) when combined with a reference chemotherapy (Capecitabine plus Cisplatin) and prolonged the median survival by nearly 3 months (from 11.1 to 13.8 months) in patients with HER2-positive(FISH+ or IHC3+) advanced GC.

Read more

Oxaliplatin has been shown to be as effective as cisplatin, and exhibits a favorable toxicity profile with a substantially lower rate of nephrotoxicity, ototoxicity, and myelosuppression.

In the current study, the efficacy and safety of Trastuzumab in combination with Oxaliplatin/capecitabine chemotherapy will be evaluated in Chinese patients with HER2 positive advanced or recurrent gastric cancer.

Read the detailed description

Trastuzumab will be administered at a loading dose of 8 mg/kg (on day 1) followed by 6mg/kg i.v. infusion every 3 weeks.

Trastuzumab is to be continued until disease progression or intolerable toxicity.

Capecitabine (Xeloda) 2000mg/m2d, d1-14; q3w, until disease progression or intolerable toxicity.

Oxaliplatin 130mg/m2 d1; q3w, 6 cycles

Conditions
Gastric Cancer
Being tested
Trastuzumab+Capecitabine+Oxaliplatin
Keywords
HER2-positive, adenocarcinoma of the stomach or gastro-esophageal junction, Inoperable, locally advanced, recurrent, metastatic
Medical subject headings
Stomach Neoplasms, Recurrence, Neoplasm Metastasis

What participants receive

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

  • Trastuzumab+Capecitabine+OxaliplatinDrug

    Also called Herceptin, Xeloda, Eloxatin

    Trastuzumab will be administered at a loading dose of 8 mg/kg (on day 1) followed by 6mg/kg i.v. infusion every 3 weeks.

    Capecitabine 2000mg/m2d, d1-14; q3w, Trastuzumab and capecitabine are to be continued until disease progression or intolerable toxicity.

    Oxaliplatin 130mg/m2 d1; q3w, 6 cycles

Study groups in NCT01364493
Study groupRoleWhat they receive
Trastuzumab+Capecitabine+OxaliplatinExperimentalTrastuzumab will be administered at a loading dose of 8 mg/kg (on day 1) followed by 6mg/kg i.v. infusion every 3 weeks. Capecitabine 2000mg/m2d, d1-14; q3w, Oxaliplatin 130mg/m2 d1; q3w, 6 cycles
Receives: Drug: Trastuzumab+Capecitabine+Oxaliplatin

What is being measured

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

  1. Objective response rate

    CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation

    Measured: 6 -8 weeks

Secondary outcomes (3)

  1. progression free survival

    the follow-up visit of PFS will be performed every 6 weeks

    Measured: 1 year

  2. overall survival of participants

    OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 3 months till death or lost

    Measured: 2 years

  3. adverse events

    participants will be followed for the duration of hospital stay, an expected average of 3 weeks

    Measured: during the treatment in the hosptital,an expected average of 3 weeks

Timeline

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

  1. First posted2 Jun 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionAug 2012
  4. Study completionFeb 2014

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01364493
Sponsor's protocol ID
CGOG1001
Status last verified
May 2017
First submitted
31 May 2011
Last updated
9 May 2017
Results posted
No
Data monitoring committee
No

Publications

  • Gong J, Liu T, Fan Q, Bai L, Bi F, Qin S, Wang J, Xu N, Cheng Y, Bai Y, Liu W, Wang L, Shen L. Optimal regimen of trastuzumab in combination with oxaliplatin/ capecitabine in first-line treatment of HER2-positive advanced gastric cancer (CGOG1001): a multicenter, phase II trial. BMC Cancer. 2016 Feb 8;16:68. doi: 10.1186/s12885-016-2092-9.

    PubMed 26857702

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab+Capecitabine+Oxaliplatin in people with Gastric Cancer, run by Peking University at 1 site in China.

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 7 inclusion and 24 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 9 May 2017. 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 China. 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?

Objective response rate (time frame: 6 -8 weeks). 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 NCT01364493, which also lists 1 linked publication.

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 9 May 2017.

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