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

NCT01123473 | Terminated Phase 2

• 3 other identifiers: EORTC-40071EU-210362009-011580-36
• Study Type: interventional
• Target: 29
• Locations: 3 countries
• Sites: 4

Brief 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.

Conditions

Adenocarcinoma of the Gastroesophageal Junction; Gastric Cancer

Keywords

adenocarcinoma of the gastroesophageal junction; adenocarcinoma of the stomach; stage IIIA gastric cancer; stage IIIB gastric cancer; stage IIIC gastric cancer; stage IV gastric cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

Secondary Outcomes (4)

• Response rate

• Overall survival

• Toxicity

• Concordance of diagnostic tests

Study Arms (2)

Lapatinib

EXPERIMENTAL

Chemotherapy + lapatinib

Drug: capecitabine; Drug: cisplatin; Drug: epirubicin hydrochloride; Drug: fluorouracil; Drug: lapatinib ditosylate

Placebo

PLACEBO COMPARATOR

Chemotherapy + placebo

Drug: capecitabine; Drug: cisplatin; Drug: epirubicin hydrochloride; Drug: fluorouracil

Interventions

capecitabine DRUG

Lapatinib; Placebo

cisplatin DRUG

Lapatinib; Placebo

epirubicin hydrochloride DRUG

Lapatinib; Placebo

fluorouracil DRUG

Lapatinib; Placebo

lapatinib ditosylate DRUG

Lapatinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (4)

Institut Jules Bordet

Brussels, Belgium

Location

U.Z. Gasthuisberg

Leuven, Belgium

Location

Johannes Gutenberg Universitaetskliniken

Mainz, Germany

Location

I.P.O. Francisco Gentil - Centro De Lisboa

Lisbon, Portugal

Location

Related Publications (1)

• Roth A, Moehler MH, Mauer M, et al.: Lapatinib in combination with ECF/x in EGFR1 or HER2-overexpressing first-line metastatic gastric cancer (GC): A phase II randomized placebo controlled trial (EORTC 40071). [Abstract] J Clin Oncol 28 (Suppl 15): A-TPS205, 2010.

  RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Capecitabine; Cisplatin; Epirubicin; Fluorouracil; Lapatinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Arnaud Roth

  Hopital Cantonal Universitaire de Geneve

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2010
• First Posted: May 14, 2010
• Study Start: December 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2014
• Last Updated: October 12, 2016

Record last verified: 2016-10

Locations

DE (1); PT (1); BE (2)