Effectiveness of first line treatment with lapatinib and ECF/X in histologically provenadenocarcinoma of the stomach or the esophagogastric junction (metastatic or notamenable to curative surgery) according to HER2 and EGFR status: a randomizedphase II trial
- Conditions
- adenocarcinoma of the stomach or the esophagogastric junction (metastatic or not amenable to curative surgery)MedDRA version: 15.0Level: PTClassification code 10063916Term: Metastatic gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-011580-36-BE
- Lead Sponsor
- EORTC - European Organisation for Research and Treatment of Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 480
¨ Histologically proven adenocarcinoma of the stomach or the esophagogastric junction, metastatic or not amenable to curative surgery
¨ Availability of tissue material for HER2 and EGFR assessment
¨ Former neoadjuvant/adjuvant chemotherapy allowed if completed = 12 months before inclusion to the study
¨ WHO Performance status 0-1
¨ Age 18 – 75 years
¨ Positive HER2 status by IHC, or positive EGFR by either FISH or IHC at time of randomization
¨ Absolute neutrophil count > 1.5 x 109/L, platelets > 100 x 109/L, hemoglobin > 9 g/dL, and white blood cell count (WBC) > 3 x 109/L within 3 weeks of randomization
¨ Renal function: Serum creatinine = 2.0 mg/dL and Calculated creatinine clearance = 60 ml/min (Cockcroft-Gault method, see appendix E) within 3 weeks of randomization
¨ Clinically normal cardiac function (LVEF =Lower Limit of Normal of the insitution and assessed by MUGA or ECHO within 21 days prior to randomization)
¨ All patients (male and female) must use effective contraception methods if of reproducing potential for the whole duration of study and until 1 month after they received the last treatment dose; Females must not be pregnant or breast-feeding at anytime during the study. Women with reproductive potential must have a pregnancy test performed within 3 weeks before randomization.
¨ Ability to swallow and retain oral medication
¨ Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations
¨ All indicated timelines and absolute values requested by the eligibility criteria must be adhered to. However, a maximum of +/- 10% of the reference value for laboratory parameters and a maximum of +/- 2 days for timelines may be acceptable.
Are the trial subjects under 18? no
Number of subjects for this age range:
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
¨ Former palliative systemic chemotherapy
¨ Prior exposure to EGFR pathway targeting therapy (antibodies or tyrosine kinase inhibitors)
¨Use of drugs or herbal constituents known to be inducers or inhibitors of CYP3A4 within 30 days prior to initiation of treatment and during treatment with lapatinib
¨ Major hepatic insufficiency (bilirubin = 1.5 x ULN and aspartate aminotransferase
(ASAT)/alanine aminotransferase (ALAT) = 3 x ULN, = 5 x ULN in case of liver metastases) within 3 weeks prior to randomization
¨ Serious cardiac illness in the past 6 months
¨ Clinical signs of CNS involvement
¨ Previous or concurrent malignancies, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix or basal cell carcinoma of the skin
¨ Other anticancer therapy or other investigational agents while on study
¨ History or evidence of interstitial pneumonitis or pulmonary fibrosis
¨ Uncontrolled infections or serious illnesses, malabsorption syndrome or medical conditions including chronic alcohol abuse, hepatitis, HIV and/or cirrhosis
¨ Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule
¨HER2+ by FISH/HER2+ by IHC2/3+
¨HER2- and EGFR- by FISH and IHC
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method