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

Phase 2
18 Years
Open (Enrolling)
GastroEsophageal Cancer

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Trial Information

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

Inclusion Criteria:

- 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.

- 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

- 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.

Exclusion Criteria:

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (ORR)

Outcome Description:

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)

Outcome Time Frame:

about 10 month (until progression)

Safety Issue:


Principal Investigator

Florian Lordick, MD

Investigator Role:

Study Director

Investigator Affiliation:

St├Ądtisches Klinikum Braunschweig


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

June 2010

Completion Date:

October 2013

Related Keywords:

  • Gastroesophageal Cancer
  • Her2 Gastro Gastric Esophageal Cancer
  • Esophageal Diseases
  • Esophageal Neoplasms