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GastroEsophageal CancerPhase 2GastroLapNCT01145404

Trial of Lapatinib Versus Lapatinib With Capecitabine in Her2+ Metastatic Gastro-Esophageal Cancer

A Phase 2 study testing Lapatinib and Lapatinib plus capecitabine in people with GastroEsophageal Cancer, run by National Center for Tumor Diseases, Heidelberg at 16 sites in Germany.

Terminated

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

Official record
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Trial summary

Combining Erb inhibitors, such lapatinib, and TS inhibitors, such as capecitabine, may be a beneficial contribution to current treatment paradigms since preclinical data suggest that lapatinib alone can decrease TS mRNA and is synergistic with capecitabine in some cell lines, which may contribute to clinical benefit. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
GastroEsophageal Cancer
What is being tested?
Lapatinib and Lapatinib plus capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
16 sitesGermany
Study dates
Jun 2010to Oct 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed adenocarcinoma of the stomach, including adenocarcinoma of the gastroesophageal junction and esophagus
  • Metastatic disease
  • Measurable disease (according to RECIST criteria)
  • At least one prior chemotherapy for metastatic disease with progression during or no later than 6 months after last administration of chemotherapy. Chemotherapy must have contained a platinum compound (cisplatin or oxaliplatin)
  • Her2 overexpression measured by FISH (amplification or increased gene copy number). Immunohistochemistry (ICH) 3+ can be included in case of an uncertain FISH test.
  • Patient willing to allow for biomarker analyses on his tumor tissue.
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  • Written informed consent given prior to any protocol specific procedures according to the local regulatory requirements
  • Age >= 18 years
  • Eastern Cooperative Oncology Group Performance Status (ECOG-PS) <= 2
  • Life expectancy > 3 months
  • Adequate hematological, hepatic and renal function defined by: Hematology: Neutrophils >1.5x109/L; Platelets >100x109/L; Hemoglobin >8g/dL Hepatic function: Total bilirubin <=1.5xULN; ASAT (SGOT) and ALAT (SGPT) <= 2.5xULN; Alkaline phosphatase <5xULN. Renal function: The calculated creatinine clearance should be .60 mL/min
  • Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of lapatinib will be determined following review of their use by the local Principal Investigator. A list of medications and substances known or with the potential to interact with CYP450 isoenzymes is provided in: Cytochrome P-450 Enzymes and Drug metabolism. In: Lacy CF, Armstrong LL, Goldman MP, Lance LL eds. Drug Information Handbook 8TH ed. Hudson, OH; LexiComp Inc. 2000: 1364-1371
  • Able to swallow and retain oral medication
  • Negative pregnancy test (urine or serum) within 28 days prior to randomization for all women of childbearing potential (has to be verified within 7 days prior to randomization and during the study according the judgement of the investigator)
  • Willingness to perform double-barrier contraception during study and 6 months after end of treatment
  • Ability to understand and the willingness to sign a written informed consent document
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Who cannot join

  • Previous non curatively treated malignant disease other than the current gastroesophageal cancer with a disease-free survival of less than 5 years
  • History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
  • History of active Hepatitis B or C or history of an HIV infection
  • Active uncontrolled infection
  • Treatment within any other clinical trial parallel to the treatment phase of the current study within 30 days prior to randomisation.
  • Concurrent treatment with any other anti-cancer drug. Presence of other medication that may interfere with study treatment or the action of the investigational product or confuse the assessment of study results
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  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or to any excipients
  • History of allergic reactions attributed to compounds of similar chemical composition to capecitabine, fluorouracil or to any excipients
  • Known DPD deficiency
  • Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors
  • Current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
  • Active cardiac disease, defined as:
  • History of uncontrolled or symptomatic angina
  • History of arrhythmias requiring medications, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation
  • Myocardial infarction < 6 months from randomization
  • Uncontrolled or symptomatic congestive heart failure (> New York Heart Association score 2)
  • Ejection fraction below the institutional normal limit
  • Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
  • Pregnancy and lactation
  • History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Germany16 sites

  • CHARITÉ CAMPUS, VIRCHOW-KLINIKUM, UNIVERSITÄTSMEDIZIN BERLIN, Centrum 14, Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie

    Berlin, 13353

  • Evangelisches Krankenhaus Bielefeld gGmbH, Klinik für Innere Medizin, Hämatologie/Onkologie und Palliativmedizin

    Bielefeld, 33611

  • Medizinische Uniklinik, Knappschaftskrankenhaus Bochum

    Bochum, 44892

  • Evangelische Kliniken Bonn gGmbH, Johanniter-Krankenhaus

    Bonn, 53113

  • Städtisches Klinikum Braunschweig gGmbH

    Braunschweig, 38114

  • Kliniken Essen Mitte, Department of Medical Oncology and Hematology

    Essen, 45136

  • Klinikum Esslingen, Klinik für Allgemeine Innere Medizin, Onkologie und Gastroenterologie

    Esslingen am Neckar, 73730

  • Krankenhaus Nord West

    Frankfurt, 60488

  • Universitätsklinikum Halle, Klinik für Innere Medizin IV

    Halle, 06120

  • OncoResearch Lerchenfeld UG

    Hamburg, 22081

  • Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie, Endokrinologie

    Hanover, 30625

  • NCT Heidelberg

    Heidelberg, 69120

  • I. Med. Klinik und Poliklinik, Universitätsmedizin der Johannes Gutenberg-Universität

    Mainz, 55101

  • Universitätsklinikum Gießen und Marburg GmbH

    Marburg, 35043

  • Klinikum rechts der Isar

    München, 81675

  • Klinikum Regensburg, Klinik und Poliklinik für Innere Medizin I

    Regensburg, 93042

Other trials in Germany

About this study

Official title: Lapatinib Versus Lapatinib With Capecitabine as Second-line Treatment in Her2-Overexpressing Metastatic Gastro-Esophageal Cancer: A Randomized Phase II Trial

Combining Erb inhibitors, such lapatinib, and TS inhibitors, such as capecitabine, may be a beneficial contribution to current treatment paradigms since preclinical data suggest that lapatinib alone can decrease TS mRNA and is synergistic with capecitabine in some cell lines, which may contribute to clinical benefit. The study described in this protocol has been designed to establish the anti-tumor activity of Lapatinib with or without capecitabine in the treatment of Her2 overexpressing metastatic gastric- and gastro-esophageal cancer, and to search for molecular correlates that may be associated with response to this compound.

The majority of patients with metastatic gastric and gastro-esophageal cancer undergo first-line combined chemotherapy (e.g. platin derivates and fluoropyrimidines, sometimes combined to a taxane), but the role of second-line chemotherapy has not yet been defined. Therefore, progression during or shortly after first-line chemotherapy is a medical condition no standard medical approach exists. The overexpression of EGFR and Her2 in gastric and gastroesophageal cancer make these indications prime candidate for treatment with the dual ErbB1/2 tyrosine kinase inhibitor (TKI) Lapatinib.

Being tested
Lapatinib, Lapatinib plus capecitabine
Keywords
Her2 Gastro Gastric Esophageal Cancer

What participants receive

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

  • LapatinibDrug

    Also called Tyverb

    Lapatinib (Tyverb) po 1500mg daily d1-21, new cycle will be started on day 22 until progression.

  • Lapatinib plus capecitabineDrug

    Also called Tyverb, Xeloda

    Lapatinib po 1250mg daily d1-21; new cycle will be started on day 22 until progression

Study groups in NCT01145404
Study groupRoleWhat they receive
Arm A: LapatinibExperimentalLapatinib (Tyverb) po 1500mg daily d1-21, new cycle will be started on day 22 until progression.
Receives: Drug: Lapatinib
Arm BExperimentalLapatinib po 1250mg daily d1-21; new cycle will be started on day 22 until progression
Receives: Drug: Lapatinib plus capecitabine

What is being measured

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

  1. Objective response rate (ORR)

    Objective response rate (ORR, complete and partial remission according to RECIST criteria

    • all to be confirmed by at least two consecutive tumor response assessments within no shorter than 4 weeks)

    Measured: about 10 month (until progression)

Secondary outcomes (4)

  1. Time to tumor progression

    Time to tumor progression

    Measured: about 10 month (until tumor progression)

  2. Overall survival

    Overall survival

    Measured: about 16 month (6 month after progression)

  3. Safety and tolerability of study treatment (for parameters see description)

    recording of AEs/SAEs, vital signs, ECG, LVEF, physical exams, lab values

    Measured: about 10 month (until progression)

  4. Biomarker analysis

    the definition of biomarkers that are associated with response or resistance to treatment

    Measured: 1 month (during screening period)

Timeline

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

  1. First posted16 Jun 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionFeb 2013
  4. Study completionOct 2013

Why it stopped: Changes of SoC for third line therapy resulting in poor recruitment

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01145404
Sponsor's protocol ID
NCT-2008-11-01-1015
Acronym
GastroLap
Status last verified
Jul 2014
First submitted
21 May 2010
Last updated
2 Jul 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Lorenzen S, Riera Knorrenschild J, Haag GM, Pohl M, Thuss-Patience P, Bassermann F, Helbig U, Weissinger F, Schnoy E, Becker K, Stocker G, Ruschoff J, Eisenmenger A, Karapanagiotou-Schenkel I, Lordick F. Lapatinib versus lapatinib plus capecitabine as second-line treatment in human epidermal growth factor receptor 2-amplified metastatic gastro-oesophageal cancer: a randomised phase II trial of the Arbeitsgemeinschaft Internistische Onkologie. Eur J Cancer. 2015 Mar;51(5):569-76. doi: 10.1016/j.ejca.2015.01.059. Epub 2015 Feb 16.

    PubMed 25694417

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lapatinib and Lapatinib plus capecitabine in people with GastroEsophageal Cancer, run by National Center for Tumor Diseases, Heidelberg at 16 sites in Germany.

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 17 inclusion and 20 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 2 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Germany. 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 was stopped early (reason given: Changes of SoC for third line therapy resulting in poor recruitment). Results are not available in the source record.

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 (ORR) (time frame: about 10 month (until progression)). 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 NCT01145404, 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 2 Jul 2014.

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