Chemotherapy With or Without Bevacizumab or Lapatinib to Treat Operable Oesophagogastric Cancer

Summary

RATIONALE: Drugs used in chemotherapy, such as epirubicin, cisplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, and small molecule tyrosine kinase inhibitors, such as lapatinib, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Lapatinib targets a specific growth receptor, HER-2. Chemotherapy together with bevacizumab or lapatinib, in HER-2 positive tumours, may kill more tumor cells.

PURPOSE: This randomized phase II/III trial is studying the side effects and how well giving combination chemotherapy together with bevacizumab works compared with combination chemotherapy alone in treating patients with previously untreated stomach cancer, gastroesophageal junction cancer or lower oesophageal cancer that can be removed by surgery. The feasibility study is studying the safety of adding lapatinib to chemotherapy in patients with HER-2 positive previously untreated stomach cancer, gastroesophageal junction cancer or lower oesophageal cancer that can be removed by surgery. The feasibility study will also assess the feasibility of timely HER-2 testing and estimate the HER-2 positivity rate in this patient population.

Conditions

• Oesophagogastric Cancer

Interventions

BIOLOGICAL

bevacizumab

7.5mg/kg IV Day 1 of each 21 cycle of chemotherapy (6 cycles) plus day 1 of each maintenance dose every 21 days for 6 doses.

DRUG

capecitabine

dose banded as based on patient BSA. Oral dose given twice a day during each 21 day cycle of chemotherapy (6 cycles in total)

DRUG

cisplatin

60mg/m2 IV day one of each 21 day cycle of chemotherapy (6 cycles in total)

DRUG

Epirubicin

50mg/m2 IV day one of each 21 day cycle of chemotherapy (6 cycles in total)

PROCEDURE

adjuvant therapy

3 cycles of ECX chemotherapy post operatively

PROCEDURE

conventional surgery

Surgery undertaken after 3 cycles of pre-operative chemotherapy. Followed by 3 cycles of chemotherapy.

PROCEDURE

neoadjuvant therapy

3 cycles of pre-operative ECX chemotherapy.

DRUG

Lapatinib

1250mg/day Day 1-21 of each cycle of chemotherapy (6 cycles) plus day 1-21 of each maintenance course every 21 days for 6 doses.

Sponsors & Collaborators

• Cancer Research UK

  collaborator OTHER

• Roche Pharma AG

  collaborator INDUSTRY

• GlaxoSmithKline

  collaborator INDUSTRY

• Professor David Cunningham

  lead OTHER_GOV

Principal Investigators

• David Cunningham, MD · Royal Marsden NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-10-31

Primary Completion

2017-12-31

Completion

2017-12-31

Countries

• United Kingdom

Study Locations