A PHASE III STUDY OF ERBB2 POSITIVE ADVANCED OR METASTATIC GASTRIC OR ESOPHAGEAL OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA TREATED WITH CAPECITABINE PLUS OXALIPLATIN WITH OR WITHOUT LAPATINIB - TRIO-CIRG 013

• Conditions: Subjects with ErbB2-positive advanced or metastatic gastric or oesophageal or gsatro-oesophageal junction adenocarcinoma; MedDRA version: 14.1Level: LLTClassification code 10001150Term: Adenocarcinoma gastricSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-005725-29-IT
• Lead Sponsor: GlaxoSmithKline Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-04
• Last Update Posted: 30 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 410

Inclusion Criteria

1. Signed informed consent; willing and able to complete all required components of study. 2. Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the esophagus or gastro-esophageal junction. Pathologic confirmation may be made from the metastatic site. Biopsy of the primary tumor is not necessary. Patients with pathologic confirmation from a metastatic site along with clinical/radiological documentation of gastric involvement and no evidence of another primary tumor are also eligible. Allowable histological subtypes include adenocarcinoma NOS, papillary carcinoma, adenocarcinoma, interstitial type, clear cell adenocarcinoma, mucinous carcinoma, signet ring cell carcinoma, undifferentiated carcinoma, carcinoma NOS. 3.Gastric cancer or Esophageal cancer that is unresectable due to locally advanced, metastatic, or locally recurrent. 4. Measurable or non-measurable, but radiologically evaluable disease, according to RECIST. X-rays, scans, or physical exams for either measurable or non-measurable disease must have been completed within 28 days prior to registration. 5. ErbB2 amplification by FISH assessed by the local or designated central laboratory. 6. Age `?¥18 years 7. ECOG Performance status `?¤ 2. 8. Adequate organ function assessed within 14 days prior randomization. 9. Cardiac ejection fraction within institutional range of normal as measured by echocardiogram. 10. Able to swallow and retain oral medications, and/or receive enteral medications via gastrectomy feeding tube. 11. Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study. 12. Prior/Concurrent Therapy-Surgery as indicate in Protocol pag.32.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Pregnant or lactating females at anytime during the study. 2.Known history of active CNS disease. 3.Uncontrolled ascites. 4.Concurrent anti-cancer therapy (chemotherapy, radiation therapy other than for pain relief, immunotherapy, biologic therapy, hormonal therapy or surgery) while taking investigational treatment. 5.Gastric carcinoid, epidermoid, sarcomas, or squamous cell carcinoma. 6.Prior palliative chemotherapy for the treatment of gastric cancer. 7.Prior treatment with oxaliplatin based neoadjuvant or adjuvant chemotherapy completed < 12 months 8.Malabsorption syndrome or uncontrolled inflammatory gastrointestinal disease (such as Crohn s disease or ulcerative colitis). 9.Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure; ô?¸ Myocardial infarction within past 6 months ô?¸ New York Association Class III or IV congestive heart failure 10. Pre-existing grade ô??? 2 motor or sensory neuropathy by CTC v3.0. 11. Uncontrolled infection. 12. 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. 13.Subjects who have 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). 14. History of other malignancy except: ô?¸ subjects who have been disease-free for 5 years ô?¸ subjects with a history of completely resected non-melanoma skin cancer ô?¸ subjects with successfully treated in situ carcinoma 15. Unresolved or unstable serious toxicity from prior administration of another investigational drug and/or prior cancer treatment. 16. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent. 17. Known history of DPD deficiency. 18. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib, capecitabine, fluorouracil, platins or their excipients. 19. Use of any investigational drug within 30 days prior randomization. 20. Use of concurrent prohibited medications that would interact with study drugs, including herbal remedies and Chinese traditional medicines for cancer, and including any medications or drugs listed in table 1.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified