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Gastric CancerPhase 3HELOISENCT01450696

A Study of Herceptin (Trastuzumab) in Combination With Cisplatin/Capecitabine Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastric or Gastro-Esophageal Junction Cancer

A Phase 3 study testing Capecitabine, Cisplatin and Herceptin in people with Gastric Cancer, run by Hoffmann-La Roche at 117 sites in 25 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This randomized, open-label, multicenter, international Phase IIIb study will compare the efficacy and safety of two Herceptin dosing regimens in combination with cisplatin/capecitabine chemotherapy in participants with HER2-positive metastatic gastric or gastro-esophageal junction adenocarcinoma. 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?
Capecitabine, Cisplatin and Herceptin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
296 participants
Where
117 sitesin 25 countries
Study dates
Dec 2011to Aug 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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-esophageal junction with metastatic disease documented to involve at least liver or lung or both
  • Measurable disease according to RECIST Version 1.1 or non-measurable evaluable disease
  • At least 2 organs involved in metastatic gastric tumor (including at least lung or liver or both) in addition to the site of primary tumor, where metastasis in distant lymph nodes, peritoneal metastasis, and malignant pleural effusion may count as "organs" in this context
  • HER2-positive primary or metastatic tumor as assessed by central laboratory
  • Adequate renal function (creatinine clearance greater than equal to (≥) 45 milliliters per minute [mL/min])
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2

Who cannot join

  • Previous chemotherapy for locally advanced or metastatic disease
  • Prior gastrectomy (partial or total) for the underlying malignant disease under investigation
  • Prior therapy with an anti-HER2 agent and/or platinum-based chemotherapeutic agent
  • Residual relevant toxicity resulting from previous therapy
  • Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (such as jejunostomy probe and gastric or jejunostomy tubes) which may impair the ability to administer or absorb capecitabine
  • Current (significant or uncontrolled) gastrointestinal bleeding
Show all 13Show fewer
  • Other malignancy within the last 5 years, except for carcinoma in situ of the cervix and basal or squamous cell carcinoma of the skin
  • History of documented congestive heart failure, angina pectoris requiring medication, electrocardiogram (ECG) evidence of transmural myocardial infraction, poorly controlled hypertension, clinically significant valvular heart disease, or high-risk uncontrollable arrhythmias
  • Baseline left ventricular ejection fraction (LVEF) less than (<) 50%, documented by echocardiography, multiple-gated radionuclide angiography (MUGA) scan, or cardiac magnetic resonance imaging (MRI)
  • Chronic or high-dose corticosteroid therapy
  • History or clinical evidence of brain metastases
  • Pregnant women
  • Active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, or HIV-seropositive

Trial locations and contacts

117 sites in 25 countries.

117 sites in 25 countries

China13 sites

  • Study site

    Beijing, 100050

  • Study site

    Beijing, 100071

  • Study site

    Beijing, 100142

  • Study site

    Beijing, 100853

  • Study site

    Changchun, 130012

  • Study site

    Changsha, 410006

  • Study site

    Changzhou, 213003

  • Study site

    Guangzhou, 510060

  • Study site

    Hangzhou, 310016

  • Study site

    Nanjing

  • Study site

    Shanghai, 200032

  • Study site

    Wuhan, 430030

  • Study site

    Zhengzhou, 450008

Other trials in China

United States9 sites

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Goshen, Indiana, 46526

  • Study site

    La Jolla, California, 92093

  • Study site

    Los Angeles, California, 90033

  • Study site

    New York, New York, 10065

  • Study site

    Portland, Oregon, 97239

  • Study site

    Whittier, California, 90603

  • Study site

    Whittier, California, 90606

  • Study site

    Wichita, Kansas, 67214-3728

Other trials in United States

Italy9 sites

  • Study site

    Ancona, The Marches, 60121

  • Study site

    Bologna, Emilia-Romagna, 40138

  • Study site

    Catanzaro, Calabria, 88100

  • Study site

    Florence, Tuscany, 50124

  • Study site

    Milan, Lombardy, 20133

  • Study site

    Naples, Campania, 80131

  • Study site

    Pisa, Tuscany, 56100

  • Study site

    Reggio Emilia, Emilia-Romagna, 42100

  • Study site

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Peru7 sites

  • Study site

    Arequipa, 04001

  • Study site

    Arequipa, 5154

  • Study site

    Lima, 1

  • Study site

    Lima, 34

  • Study site

    Lima, Lima 1

  • Study site

    Lima, Lima 41

  • Study site

    Trujillo, 13011

Other trials in Peru

South Korea7 sites

  • Study site

    Bundang City, 463-802

  • Study site

    Incheon, 405-760

  • Study site

    Seoul, 03722

  • Study site

    Seoul, 06351

  • Study site

    Seoul, 110-744

  • Study site

    Seoul, 130-872

  • Study site

    Seoul, 135-720

Other trials in South Korea

Turkey (Türkiye)7 sites

  • Study site

    Adana, 01250

  • Study site

    Gaziantep, 27100

  • Study site

    Istanbul, 34890

  • Study site

    Izmir, 35100

  • Study site

    Izmir, 35340

  • Study site

    Malatya, 44280

  • Study site

    Sıhhiye, Ankara, 06100

Other trials in Turkey (Türkiye)

Hungary6 sites

  • Study site

    Budapest, 1097

  • Study site

    Budapest, 1145

  • Study site

    Pécs, 7623

  • Study site

    Szolnok, 5004

  • Study site

    Szombathely, 9700

  • Study site

    Veszprém, 8200

Other trials in Hungary

Russia6 sites

  • Study site

    Ivanovo, 153040

  • Study site

    Omsk, 644013

  • Study site

    Ryazan, 390011

  • Study site

    Saint Petersburg

  • Study site

    Stavropol, 355045

  • Study site

    Tula, 300053

Other trials in Russia

Ukraine6 sites

  • Study site

    Cherkassy, 18009

  • Study site

    Chernivtsi, 58013

  • Study site

    Dnipropetrovsk, 49102

  • Study site

    Donetsk, 83092

  • Study site

    Kiev, 03115

  • Study site

    Lviv, 79031

Other trials in Ukraine

Brazil5 sites

  • Study site

    Barretos, São Paulo, 14784-400

  • Study site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Study site

    Rio de Janeiro, Rio de Janeiro, 20560-120

  • Study site

    São Paulo, São Paulo, 01246-000

  • Study site

    Sorocaba, São Paulo, 18030-245

Other trials in Brazil

Australia4 sites

  • Study site

    Murdoch, Western Australia, 6150

  • Study site

    Port Macquarie, New South Wales, 2444

  • Study site

    Wahroonga, New South Wales, 2076

  • Study site

    Woodville South, South Australia, 5011

Other trials in Australia

Czechia4 sites

  • Study site

    Brno, 656 53

  • Study site

    Olomouc, 775 20

  • Study site

    Prague, 128 08

  • Study site

    Prague, 180 81

Other trials in Czechia

Mexico4 sites

  • Study site

    Distrito Federal, 14080

  • Study site

    Mexico City, 06760

  • Study site

    Monterrey, 64020

  • Study site

    Oaxaca City, 68000

Other trials in Mexico

Poland4 sites

  • Study site

    Krakow, 31-501

  • Study site

    Lublin, 20-090

  • Study site

    Warsaw, 00-973

  • Study site

    Wieliszew, 05-135

Other trials in Poland

United Kingdom4 sites

  • Study site

    Denbighshire, LL185UJ

  • Study site

    Leicester, LE1 5WW

  • Study site

    Southampton, SO16 6YD

  • Study site

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Chile3 sites

  • Study site

    Santiago, 7500921

  • Study site

    Santiago, 8380456

  • Study site

    Viña del Mar, 2520612

Other trials in Chile

Germany3 sites

  • Study site

    Berlin, 10117

  • Study site

    Frankfurt, 60488

  • Study site

    Mannheim, 68167

Other trials in Germany

Serbia3 sites

  • Study site

    Belgrade, 11000

  • Study site

    Kamenitz, 21204

  • Study site

    Niš, 18000

Other trials in Serbia

South Africa3 sites

  • Study site

    Bloemfontein, 9300

  • Study site

    Cape Town, 7506

  • Study site

    Johannesburg, 2193

Other trials in South Africa

Spain3 sites

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    Barcelona, Barcelona, 08041

  • Study site

    Madrid, Madrid, 28046

Other trials in Spain

Bosnia and Herzegovina2 sites

  • Study site

    Banja Luka, 78000

  • Study site

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

Philippines2 sites

  • Study site

    Manila, 1000

  • Study site

    Pasig, 1605

Other trials in Philippines

New Zealand1 site

  • Study site

    Auckland, 1023

Other trials in New Zealand

Panama1 site

  • Study site

    Panama City, 0834-02723

Other trials in Panama

Portugal1 site

  • Study site

    Porto, 4200-072

Other trials in Portugal

About this study

Official title: A Randomized, Open Label, Multicenter Phase IIIb Study Comparing Two Trastuzumab Dosing Regimens, Each in Combination With Cisplatin/Capecitabine Chemotherapy, as First-Line Therapy in Patients With HER2-Positive Metastatic Gastric or Gastro-Esophageal Junction Adenocarcinoma Who Have Not Received Prior Treatment for Metastatic Disease

This randomized, open-label, multicenter, international Phase IIIb study will compare the efficacy and safety of two Herceptin dosing regimens in combination with cisplatin/capecitabine chemotherapy in participants with HER2-positive metastatic gastric or gastro-esophageal junction adenocarcinoma. Participants who have not received prior treatment for metastatic disease will be randomized to receive Herceptin intravenously as either an 8-milligram per kilogram (mg/kg) loading dose followed by 6 mg/kg every 3 weeks (q3w) as standard of care or an 8-mg/kg loading dose followed by 10 mg/kg q3w until disease progression. Capecitabine will be administered for 6 cycles at a dose of 800 milligrams per meter-squared (mg/m^2) orally twice a day on Days 1 to 14 of each 3-week cycle, and cisplatin will be administered intravenously for 6 cycles at a dose of 80 mg/m^2 on Day 1 of each 3-week cycle. Herceptin will be continued until disease progression occurs.

Conditions
Gastric Cancer
Being tested
Capecitabine, Cisplatin, Herceptin
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • CapecitabineDrug

    Capecitabine will be administered at a dose of 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 cycles (Cycles 1 to 6).

  • CisplatinDrug

    Cisplatin will be administered at a dose of 80 mg/m^2 intravenously q3w on Day 1 of each 3-week cycle for up to 6 cycles (Cycles 1 to 6).

  • HerceptinDrug

    Also called Trastuzumab

    Herceptin will be administered at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 or 10 mg/kg (depending upon treatment assignment) q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.

Study groups in NCT01450696
Study groupRoleWhat they receive
Capecitabine + Cisplatin + Herceptin (6 mg/kg)Active comparatorParticipants will receive Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as a standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants will also receive cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
Receives: Drug: Capecitabine; Drug: Cisplatin; Drug: Herceptin
Capecitabine + Cisplatin + Herceptin (10 mg/kg)ExperimentalParticipants will receive Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants will also receive cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
Receives: Drug: Capecitabine; Drug: Cisplatin; Drug: Herceptin

What is being measured

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

  1. Percentage of Participants Who Died - FAS

    The percentage of participants who died as of the analysis data cutoff date of 13 February 2015 was reported among participants from the FAS with available data.

    Measured: From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)

  2. Overall Survival - FAS

    Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival was estimated among participants from the FAS using the Kaplan-Meier approach. The 95 percent (%) confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley.

    Measured: From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)

Secondary outcomes (7)

  1. Percentage of Participants Who Died - Per Protocol Set (PPS)

    The percentage of participants who died as of the analysis data cutoff date of 13 February 2015 was reported among participants from the PPS.

    Measured: From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)

  2. Overall Survival - PPS

    Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival was estimated among participants from the PPS using the Kaplan-Meier approach. The 95% CI for median was computed using the method of Brookmeyer and Crowley.

    Measured: From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)

  3. Percentage of Participants With Disease Progression or Death - PPS

    Disease progression was defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including Baseline (nadir). In addition to the relative increase of 20%, the sum was also required to demonstrate an absolute increase of ≥5 millimeters (mm). The percentage of participants who died or experienced disease progression as of the analysis data cutoff date of 13 February 2015 was reported among participants from the PPS.

    Measured: From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015)

  4. Progression-Free Survival - PPS

    Progression-free survival was defined as the time between the day of randomization and the date of first documentation of disease progression or date of death, whichever occurred first, measured following RECIST Version 1.1 criteria. Disease progression was defined as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including Baseline (nadir). In addition to the relative increase of 20%, the sum was also required to demonstrate an absolute increase of ≥5 mm. The 95% CI for median was computed using the method of Brookmeyer and Crowley.

    Measured: From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015)

  5. Percentage of Participants With Objective Response - PPS

    Objective response was defined as the occurrence of either a complete response (CR) or partial response (PR) as determined by RECIST Version 1.1 based on investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) were required to have reduction in short axis to <10 mm. PR was defined as a ≥30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. The 95% CI was constructed using Blyth-Still-Casella method.

    Measured: From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015)

  6. Trastuzumab Cmin on Day 21 of Cycles 1 to 11 - FAS

    Cmin samples were obtained in all participants randomized to receive Herceptin (FAS). The observed Cmin was recorded, averaged among all participants, and expressed in μg/mL.

    Measured: Day 21 of Cycle 1, 2, 3, 4, 5, 7, 9, 11 (cycle length = 21 days)

  7. Trastuzumab Serum Concentration on Day 1 of Cycle 1 - FAS

    Trastuzumab serum concentration samples were obtained in all participants randomized to receive Herceptin (FAS). The observed concentration values were recorded, averaged among all participants, and expressed in μg/mL.

    Measured: Pre-dose (0 minutes) and within 15 minutes after end of 2-hour Herceptin infusion on Day 1 of Cycle 1 (cycle length = 21 days)

Timeline

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

  1. First posted12 Oct 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionFeb 2015
  4. Study completionAug 2015

Why it stopped: futility following planned interim analysis

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
296 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01450696
Sponsor's protocol ID
BO27798
Other IDs
2011-001526-19
Acronym
HELOISE
Status last verified
Oct 2016
First submitted
10 Oct 2011
Last updated
28 Nov 2016

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Capecitabine, Cisplatin and Herceptin in people with Gastric Cancer, run by Hoffmann-La Roche at 117 sites in 25 countries.

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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in China, United States, Italy, Peru, South Korea and 20 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Who Died - FAS (time frame: From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)). The study lists 2 primary outcomes in all. 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 NCT01450696.

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 28 Nov 2016.

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