Clinical trial NCT00450203: Chemotherapy With or Without Bevacizumab or Lapatinib to Treat Operable Oesophagogastric Cancer
Official title: A Randomised Phase II/III Trial of Peri-Operative Chemotherapy With or Without Bevacizumab in Operable Oesophagogastric Adenocarcinoma and A Feasibility Study Evaluating Lapatinib in HER-2 Positive Oesophagogastric Adenocarcinomas and (in Selected Centres) MRI and PET/CT Sub-studies
Conditions: 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.
Interventions:
description: 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.
name: bevacizumab
type: Biological
description: dose banded as based on patient BSA. Oral dose given twice a day during each 21 day cycle of chemotherapy (6 cycles in total)
name: capecitabine
type: Drug
description: 60mg/m2 IV day one of each 21 day cycle of chemotherapy (6 cycles in total)
name: cisplatin
type: Drug
description: 50mg/m2 IV day one of each 21 day cycle of chemotherapy (6 cycles in total)
name: Epirubicin
type: Drug
description: 3 cycles of ECX chemotherapy post operatively
name: adjuvant therapy
type: Procedure
description: Surgery undertaken after 3 cycles of pre-operative chemotherapy. Followed by 3 cycles of chemotherapy.
name: conventional surgery
type: Procedure
description: 3 cycles of pre-operative ECX chemotherapy.
name: neoadjuvant therapy
type: Procedure
description: 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.
name: Lapatinib
other_name: Tyverb
type: Drug
Study arms:
design_group_description: ECX + Bevacizumab
design_group_title: ECX + Bevacizumab
design_group_type: Experimental
design_group_description: ECX chemotherapy
design_group_title: Epirubicin, Cisplatin and Capecitabine
design_group_type: Active Comparator
design_group_description: ECX + Lapatinib
design_group_title: ECX + Lapatinib
design_group_type: Experimental
Sponsor: The Medical Research Council
Collaborators: Roche Pharma AG
GSK Plc
Cancer Research UK
Drug name mappings:
name: 二甲苯磺酸拉帕替尼
lang: CN
name: Lapatinib Ditosylate Hydrate
lang: EN
name: 顺铂
lang: CN
name: Cisplatin
lang: EN
name: シスプラチン
lang: JP
name: 贝伐珠单抗
lang: CN
name: Bevacizumab
lang: EN
name: ベバシズマブ（遺伝子組換え）
lang: JP
name: 盐酸表柔比星
lang: CN
name: Epirubicin Hydrochloride
lang: EN
name: エピルビシン塩酸塩
lang: JP
name: 卡培他滨
lang: CN
name: Capecitabine
lang: EN
name: カペシタビン
lang: JP