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

• Status: Terminated
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as epirubicin hydrochloride, cisplatin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving combination chemotherapy together with or without lapatinib ditosylate is more effective in treating patients with cancer of the stomach or gastroesophageal junction.

PURPOSE: This randomized phase II trial is studying how well epirubicin hydrochloride, cisplatin, and fluorouracil or capecitabine works when given together with or without lapatinib ditosylate as first-line therapy in treating patients with stomach cancer or gastroesophageal junction cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Capecitabine; Cisplatin; Epirubicin; Fluorouracil; Lapatinib

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