LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib

Tracking Information

Start Date  ICMJEJune 2008
Primary Completion Date 
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2008)
Progression-free survival to be compared between patients treated with CapeOx plus lapatinib vs CapeOx plus placebo; Progression will be evaluated according to RECIST criteria and at regular intervals
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00680901 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: May 15, 2008)
Overall survival, response rate, and duration of responses, rate of clinical benefit, safety, quality of life, pharmacoeconomics, pharmacogenetics, and biomarker exploratory analysis
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJELOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib
Official Title  ICMJEA Phase III Study for ErbB2 Positive Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Adenocarcinoma Treated With Capecitabine Plus Oxaliplatin With or Without Lapatinib
Brief Summary

This is an international multi-center trial that will enroll patients with locally advanced, unresectable, or metastatic gastric, esophageal, or gastro-esophageal junction cancer whose tumors have amplification of the ErbB2 (HER2) gene. The trial will investigate whether lapatinib, when added to the chemotherapy regimen, capecitabine plus oxaliplatin (CapeOx), extends the time to progression and overall survival. Tumor ErbB2 (HER2) status must be known before trial entry. CapeOx is administered to all patients, and patients will be randomly assigned to receive either lapatinib or placebo.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • ErbB2 (HER2) Amplified Gastric
  • Esophageal
  • or Gastro-esophageal Junction Adenocarcinoma That is Unresectable Due to Locally Advanced Metastatic, or Locally Recurrent Disease.
Intervention  ICMJEDrug: Lapatinib
Other Name: Lapatinib
Study Arms / Comparison Groups 

Recruitment Information

Estimated Enrollment  ICMJE410
Completion Date 
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

Signed informed consent; Histologically confirmed gastric, esophageal, or gastro-esophageal junction adenocarcinoma; disease that is unresectable due to locally advanced, 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 or the regimen CapeOx; 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

Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: US GSK Clinical Trials Call Center877-379-3718
Location Countries  ICMJEUnited States,   Argentina,   Brazil,   Canada,   Chile,   China,   Estonia,   Hong Kong,   India,   Italy,   Korea, Republic of,   Netherlands,   Peru,   Poland,   Russian Federation,   Taiwan,   Ukraine

Administrative Information

Responsible PartyStudy Director, GSK
Study ID Numbers  ICMJEEGF110656, EGF110656-TRIO-CIRG 013
Study Sponsor  ICMJEGlaxoSmithKline
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:GSK Clinical Trials, MDGlaxoSmithKline
Information Provided ByGlaxoSmithKline