Epirubicin Hydrochloride, Cisplatin, and Fluorouracil or Capecitabine With or Without Lapatinib Ditosylate as First-Line Therapy in Treating Patients With Stomach Cancer or Gastroesophageal Junction Cancer

Launched by EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER - EORTC · May 13, 2010

Keywords

ClinConnect Summary

OBJECTIVES:

Primary

* To determine the activity of first-line treatment comprising epirubicin hydrochloride, cisplatin, and fluorouracil or capecitabine with or without lapatinib ditosylate in patients with adenocarcinoma of the stomach or esophagogastric junction that is metastatic or not amenable to curative surgery according to HER2 and EGFR status.

Secondary

* To explore the activity of this regimen in patients who are HER2 negative by FISH, but HER2 positive by IHC (2+ and 3+) as well as patients who are HER2 positive or negative by FISH and negative by IHC (0 or 1+), but EGFR posi...

Gender

ALL

Eligibility criteria

• DISEASE CHARACTERISTICS:
• • Histologically confirmed adenocarcinoma of the stomach or the esophagogastric junction
• • Metastatic disease OR not amenable to curative surgery
• • Tissue material for HER2 and EGFR assessment must be available
• • Positive HER2 status by immunohistochemistry (IHC) OR positive EGFR by either fluorescence in situ hybridization (FISH) or IHC at time of randomization
• • No clinical signs of CNS involvement
• PATIENT CHARACTERISTICS:
• • WHO performance status 0-1
• • WBC \> 3 x 10\^9/L
• • Absolute neutrophil count \> 1.5 x 10\^9/L
• • Platelet count \> 100 x 10\^9/L
• • Hemoglobin \> 9 g/dL
• • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• • AST/ALT ≤ 3 times ULN (≤ 5 times ULN in case of liver metastases)
• • Serum creatinine ≤ 2.0 mg/dL
• • Creatinine clearance ≥ 60 mL/min
• • Not pregnant or nursing
• • Negative pregnancy test
• • Fertile patients must use effective contraception during and for 1 month after completion of study therapy
• • LVEF normal by MUGA scan or ECHO
• • No serious cardiac illness within the past 6 months
• • No previous or concurrent malignancies except for adequately treated cone-biopsied carcinoma in situ of the cervix or basal cell carcinoma of the skin
• • Able to swallow and retain oral medication
• • No history or evidence of interstitial pneumonitis or pulmonary fibrosis
• • No uncontrolled infections or serious illnesses, malabsorption syndrome, or medical conditions including chronic alcohol abuse, hepatitis, HIV, and/or cirrhosis
• • No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol or follow-up schedule
• PRIOR CONCURRENT THERAPY:
• • At least 12 months since prior neoadjuvant or adjuvant chemotherapy
• • No other investigational drugs from 28 days prior to the first dose of study treatment until 30 days after the last dose of study treatment
• • At least 30 days since prior and no concurrent drugs or herbal constituents known to be inducers or inhibitors of CYP3A4
• • No prior palliative systemic chemotherapy
• • No prior EGFR pathway-targeting therapy (e.g., antibodies or tyrosine kinase inhibitors)
• • No concurrent traditional Chinese medicines
• • No concurrent non-drug therapies such as radiotherapy (other than for pain relief) or surgery
• • No other concurrent anticancer therapy or investigational agents
• • No concurrent grapefruit or its juice