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A Phase III Study for ErbB2 Positive Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Adenocarcinoma Treated With Capecitabine Plus Oxaliplatin With or Without Lapatinib


Phase 3
18 Years
N/A
Open (Enrolling)
Both
or Gastro-esophageal Junction Adenocarcinoma That is Unresectable Due to Locally Advanced Metastatic, or Locally Recurrent Disease., ErbB2 (HER2) Amplified Gastric, Neoplasms, Gastrointestinal Tract, Esophageal

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Trial Information

A Phase III Study for ErbB2 Positive Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Adenocarcinoma Treated With Capecitabine Plus Oxaliplatin With or Without Lapatinib


Inclusion Criteria:



Signed informed consent; Histologically confirmed gastric, esophageal, or
gastro-esophageal junction adenocarcinoma; disease that is locally advanced
(unresectable), metastatic, or locally recurrent disease; Measurable or non-measurable,
but radiologically evaluable disease, according to RECIST; ErbB2 (HER2)positive; Age =18
years; ECOG Performance status = 2; Adequate organ function, including adequate
hematologic, renal and liver function; Cardiac ejection fraction within institutional
range of normal as measured by echocardiogram; Able to swallow and retain oral
medications, and/or receive enteral medications via gastrectomy feeding tube; Women and
men with potential to have children must be willing to practice acceptable methods of
birth control during the study; Prior gastric surgery is permitted if > 3 weeks prior and
recovered; Prior chemotherapy for non-gastric malignancy if > than 5 years; Prior
neoadjuvant and/or adjuvant chemotherapy for early stage gastric cancer if > 6 months
since completion; At least 4 weeks since prior radiotherapy; Prior biologic, hormonal, or
immunologic cancer treatment if > 5 years since treatment.

Exclusion Criteria:

Pregnant or lactating females; Known history of active CNS disease; Uncontrolled ascites;
Concurrent anti-cancer therapy; Gastric carcinoid, epidermoid, sarcomas, or squamous cell
carcinoma; Prior palliative chemotherapy for the treatment of gastric cancer; Prior
treatment with oxaliplatin < 12 months; Malabsorption syndrome or uncontrolled
inflammatory gastrointestinal disease; Known history of uncontrolled or symptomatic
angina, arrhythmias, or congestive heart failure; Pre-existing grade = 2 motor or sensory
neuropathy; Uncontrolled infection; Concurrent disease or condition that would make the
subject inappropriate for study participation or any serious medical condition that would
interfere with the subject''s safety; Active hepatic or biliary disease; History of other
malignancy except if disease-free for 5 years, a history of completely resected
non-melanoma skin cancer, or a successfully treated in situ carcinoma; Unresolved or
unstable serious toxicity from prior administration of another investigational drug and/or
prior cancer treatment; Dementia, altered mental status, or any psychiatric condition that
would prohibit the understanding or rendering of informed consent; Known history of DPD
deficiency; Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to lapatinib, capecitabine, fluorouracil, platins or their excipients;
Use of any investigational drug within 30 days prior randomization; Use of concurrent
prohibited medications that would interact with study medications

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall survival to be compared between patients treated with CapeOx plus lapatinib vs CapeOx plus placebo

Outcome Time Frame:

until end of study approxamately 18 months from last subject randomized

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

China: Food and Drug Administration

Study ID:

EGF110656

NCT ID:

NCT00680901

Start Date:

March 2001

Completion Date:

February 2015

Related Keywords:

  • or Gastro-esophageal Junction Adenocarcinoma That is Unresectable Due to Locally Advanced Metastatic, or Locally Recurrent Disease.
  • ErbB2 (HER2) Amplified Gastric
  • Neoplasms, Gastrointestinal Tract
  • Esophageal
  • unresectable
  • HER2
  • metastatic
  • CapeOx
  • capecitabine
  • lapatinib
  • ErbB2
  • GE junction
  • TYKERB
  • gastric/esophageal cancer
  • oxaliplatin
  • TYVERB
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Esophageal Diseases
  • Digestive System Neoplasms
  • Gastrointestinal Neoplasms

Name

Location

GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteIndianapolis, Indiana  46260
GSK Investigational SiteHenderson, Nevada  89014