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

Sponsor
Professor David Cunningham
Study ID
NCT00450203
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • Oesophagogastric Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
    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.
  • capecitabine — DRUG
    dose banded as based on patient BSA. Oral dose given twice a day during each 21 day cycle of chemotherapy (6 cycles in total)
  • cisplatin — DRUG
    60mg/m2 IV day one of each 21 day cycle of chemotherapy (6 cycles in total)
  • Epirubicin — DRUG
    50mg/m2 IV day one of each 21 day cycle of chemotherapy (6 cycles in total)
  • adjuvant therapy — PROCEDURE
    3 cycles of ECX chemotherapy post operatively
  • conventional surgery — PROCEDURE
    Surgery undertaken after 3 cycles of pre-operative chemotherapy. Followed by 3 cycles of chemotherapy.
  • neoadjuvant therapy — PROCEDURE
    3 cycles of pre-operative ECX chemotherapy.
  • Lapatinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 31, 2007
Status verified
Nov 2016
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017

Study Design

Enrollment
1,103 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ECX + Bevacizumab
    ECX + Bevacizumab
  • Active Comparator: Epirubicin, Cisplatin and Capecitabine
    ECX chemotherapy
  • Experimental: ECX + Lapatinib
    ECX + Lapatinib

Primary Outcome Measure

Safety [ Time Frame: at the end of phase II and phase III ]

Central Contacts