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Stage IV Gastric Cancer With MetastasisPhase 2HerXONCT01503983

Efficacy and Safety of Trastuzumab, Capecitabine y Oxaliplatine as Treatment Gastric Cancer Metastatic (HER2)Positive

A Phase 2 study testing Trastuzumab, Capecitabine and Oxaliplatin in people with Stage IV Gastric Cancer With Metastasis, run by Fundación para el Progreso de la Oncología en Cantabria at 13 sites in Spain.

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

The objective of the study is assess the efficacy and safety of Trastuzumab in combination with Capecitabine+Oxaliplatin as first-line treatment of patients with advanced or metastatic gastric cancer or gastro-esophageal junction, (HER2)-positive. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stage IV Gastric Cancer With Metastasis
What is being tested?
Trastuzumab, Capecitabine and Oxaliplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
13 sitesSpain
Study dates
Aug 2011to May 2015
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

  • Patients be able to grant a written informed consent or oral consent
  • Age ≥18 years old
  • Patients diagnosed with metastatic gastric or gastro-esophageal junction adenocarcinoma (HER2-positive), unresectable and histologically confirmed Measurable disease, following the new RECIST criteria,
  • HER2 positive tumors (primary or metastatic) with overexpression HER2 determinated by IHQ +++ (IHQ3+) o IHQ ++ confirmed by FISH/SISH positive (IHQ2+/FISH+)
  • ECOG ≤ 2
  • Patients of childbearing potential (< 12 months from last menstruation), they have to use effective means of contraception
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  • Life expectancy more than 3 months
  • Adequate renal function: calculated creatinine clearance > 50 mL/min
  • Adequate liver function: AST and ALT ≤2.5 x LSN (5 x LSN with liver metastasis), bilirubin 1,5 x LSN. alkaline phosphatase < 2,5 x LSN (≤ 5 x LSN with liver metastasis o < 10 x LSN with bone metastases Adequate haematological function: Hb ≥9 g/dl, neutrophils ≥ 1,5 x 109 /l and platelets 100 x 109 /l.
  • Normal Left Ventricle Fraction Ejection , LVEF> 50%
  • Every patient should be treated and followed in his / her study site

Who cannot join

  • Prior chemotherapy treatment for advanced/metastatic disease
  • Lack of physical integrity of the upper gastrointestinal tract or malabsorption
  • Patients with active gastrointestinal bleeding
  • Prior chemotherapeutic treatment for advanced / metastatic disease
  • Toxicity as a result of prior therapy (except alopecia)., for example.
  • Neurology toxicity grade ≥2NCI-CTCAE
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  • Patients who received radiotherapy within 4 weeks prior to study treatment.
  • Major surgical procedures within 4 weeks prior to treatment without a total surgical recovery.
  • Past or current history of other malignancies (within the last 5-2 years prior to treatment start), patients with curatively treated basal cell carcinoma of the skin or in situ carcinoma of the cervix are eligible
  • Active and clinically significant cardiovascular disease,
  • History or current clinical evidence of brain metastasis
  • Patients undergoing transplantation allogenic requiring immunosuppressive treatment
  • Moderate or severe renal failure, creatinine clearance < 50 mL/min, calculated by Cockcroft-Gault
  • Adequate liver function: bilirubin ≤1.5 x UL, GOT ( ASAT )/ GPT ( ALAT ) ≤2,5 LSN. Liver metastasis ≤ 5 x LSN, FA ≤ de 2,5 feces el LSN.
  • Adequate haematology function: neutrophils ≥ 1,5 x 109 /l and platelets 100 x 109 /l
  • Treatment with sorivudine and the analogous as brivudine.
  • Dihydropyrimidine proven dehydrogenase deficiency (DPD).
  • Patients who had received any drug, agent or investigational procedure, or who have participated in another research study within 30 days prior to initiation of treatment with study medication.
  • Hypersensitivity to any of the study drugs
  • Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
  • Patients receiving chronic corticosteroid therapy or high dose (is allowed to use inhaled steroids and cycle short treatment with oral steroids for prevention of emesis or to stimulate appetite)
  • Pregnancy and lactation
  • Patients of childbearing potential not willing to use effective means of contraception.
  • History of psychiatric disorders that the investigator considered clinically significant, causing the patient give informed consent or interfere with compliance with study procedures.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Spain13 sites

  • Hospital Juan Canalejo

    A Coruña, A Coruña, 15006

  • Centro Oncológico de Galicia

    A Coruña, A Coruña, 15009

  • Hospital de Basurto

    Bilbao, Bilbao, 48013

  • Hospital Arnau de Vilanova de LLeida

    Lleida, Lleida, 25198

  • Hospital Lucus Augusti de Lugo

    Lugo, A Coruña, 27003

  • Hospital Gregorio Marañon

    Madrid, Madrid, 28009

  • Hospital La Paz

    Madrid, Madrid, 28046

  • Hospital de Orense

    Ourense, Orense, 32005

  • Hospital Universitario Cnetral de Asturias

    Oviedo, Oviedo, 33006

  • Hospital Provincial de Pontevedra

    Pontevedra, Vigo, 36001

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Xeral Cies

    Vigo, Vigo, 36204

  • Hospital de POVISA

    Vigo, Vigo, 36211

Other trials in Spain

About this study

Official title: Phase II Study to Assess the Efficacy and Safety of Trastuzumab in Combination With Xelox as First-line Treatment of Patients With Advanced or Metastatic Gastric Cancer or Gastro-esophageal Junction, (HER2)-Positive.

The objective of the study is assess the efficacy and safety of Trastuzumab in combination with Capecitabine+Oxaliplatin as first-line treatment of patients with advanced or metastatic gastric cancer or gastro-esophageal junction, (HER2)-positive.

Read the detailed description

Gastric cancer worldwide is the second tumor incidence (10%). There are significant geographical differences in Spain with an incidence of 15 cases/100,000 per year. Although the incidence and mortality of gastric cancer (GC) have experienced a marked reduction in the past 40 years, this disease remains a leading cause of cancer-related mortality, accounting for more than 870,000 deaths worldwide in the year 2000.

Gastric cancer has a high mortality rate because usually diagnosed when in advanced stage and in many cases has a high relapse rate. Advanced gastric cancer cases are considered to be diagnosed with unresectable disease, either by having locally advanced disease (30% of cases at diagnosis), or having metastatic disease (another 30%) and patients with relapses (60% of resected). Thus, overall around 84% of patients with gastric cancer will have advanced disease.

The only curative treatment so far is surgery. Thanks to early detection and implementation of appropriate surgical techniques, survival has improved in some countries such as Japan and Korea, being the rate of 5-year survival of 47%Over the years, a large number of studies with a single agent chemotherapy has been shown that gastric cancer is a relatively sensitive to chemotherapy. Based on these observations, the trend was the investigation of the combination of chemotherapy agents.

Based on these results FDA and EMEA has approved capecitabine in the treatment of advance gastric cancer combined with platinum.

Keywords
Gastric Cancer with Metastasis, HER2-positive

What participants receive

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

  • TrastuzumabDrug

    Also called Herceptin

    Trastuzumab: 8 mg/kg day 1 followed by 6 mg/kg every 3 weeks (i.v.)

  • CapecitabineDrug

    Also called Xeloda

    Capecitabine: 1000 mg/m2/12h/days 1 - 14 every 3 weeks (v.o.)

  • OxaliplatinDrug

    Also called Oxaliplatino

    Oxaliplatin: 130 mg/m2 in 2 h, day 1 / (i.v.) /every 3 weeks

Study groups in NCT01503983
Study groupRoleWhat they receive
Trastuzumab+Oxaliplatine+capecitabineExperimentalPatient takes Trastuzumab (initial dose 8 mg/kg and a maintenance dose 6 mg/kg) anda oxaliplatin (dose 130mg/m2) during the first day os cycle and them Capecitabine (dose 2000 mg/m2)during 14 days in cycle of 21 days.
Receives: Drug: Trastuzumab; Drug: Capecitabine; Drug: Oxaliplatin

What is being measured

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

  1. Overall Survival

    Overall survival defined as the time from start of treatment until the patient's death

    Measured: up to 10 Months

Secondary outcomes (4)

  1. progression free survival

    Progression free survival defined as time from start of treatment until date of progression were observed according to RECIST 1.1

    Measured: 5 months

  2. the time to progression

    Time to progression defined as time elapsed since the beginning of treatment until disease progression

    Measured: 5 months

  3. duration of response

    Duration of response defined as the time since the objective complete or partial response until there is disease progression

    Measured: 10 months

  4. time to response

    Time to response, defined as the time from initiation of treatment until objective complete or partial response

    Measured: 10 months

Timeline

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

  1. First posted4 Jan 2012 (estimated)
  2. Study startAug 2011
  3. Primary completionDec 2013
  4. Study completionMay 2015

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
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01503983
Sponsor's protocol ID
FUPOCAN-01-11
Other IDs
2011-001231-23
Acronym
HerXO
Status last verified
Apr 2012
First submitted
7 Dec 2011
Last updated
27 Aug 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab, Capecitabine and Oxaliplatin in people with Stage IV Gastric Cancer With Metastasis, run by Fundación para el Progreso de la Oncología en Cantabria at 13 sites in Spain.

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 11 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 27 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Spain. 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 Survival (time frame: up to 10 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 NCT01503983.

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 27 Aug 2015.

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