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

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT01123473
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • capecitabine — DRUG
  • cisplatin — DRUG
  • epirubicin hydrochloride — DRUG
  • fluorouracil — DRUG
  • lapatinib ditosylate — DRUG

Study Details

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.

Key Dates

Start date
Dec 31, 2010
Status verified
Oct 2016
Primary completion
Aug 31, 2013
Completion
Sep 30, 2014

Study Design

Enrollment
29 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lapatinib
    Chemotherapy + lapatinib
  • Placebo Comparator: Placebo
    Chemotherapy + placebo

Primary Outcome Measure

Progression-free survival

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