COG

STUDY STATUS

Closed to recruitment.

COG has reached its target of 450 patients.
Number of active sites: 51 (October 2011)

STUDY SCHEMA

INCLUSION CRITERIA

• Age >18 years
• Oesophageal cancers and type I and type II junctional tumours
• Histologically proven adenocarcinoma, squamous cell cancer or poorly differentiated epithelial malignancy
• Failure after previous chemotherapy. Treatment not to start until at least 6 weeks from the last day of chemotherapy (including oral)
• WHO Performance Status: 0, 1 or 2
• Measurable or evaluable disease by CT scan
• Able to take tablets (whole or dispersed)
• Patients with brain metastases must be stable and have received cranial irradiation prior to entry (tick YES if N/A)

EXCLUSION CRITERIA

• More than 2 previous chemotherapy regimens and 1 chemoradiation course
• Presence of previous or other malignancy likely to confound results or interfere with gefitinib therapy
• Medical condition considered to interfere with the safe participation in the trial
• Radiotherapy to site of measurable or evaluable disease in the last 4 weeks
• Pregnancy (tick NO if patient is male)
• Sexually active patients of child-bearing potential not using adequate contraception* (male and female) [post menopausal women must have been amenorrheic for at least 12 months to be considered as having non-child-bearing potential]
• Serum bilirubin greater than 3 times the upper limit of reference range (ULRR) 
• Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x ULN if no demonstrable liver metastases (or >5 x in presence of liver metastases)
• Any evidence of clinically active Interstitial Lung Disease (ILD) (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
• Known severe hypersensitivity to gefitinib or any of the excipients of this products
• On cytotoxic chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids) or experimental medications

* For female trial participants: birth control pills, approved contraceptive implant, spermicidal foam and condoms, intrauterine device, or prior tubal ligation. For male trial participants: condoms and spermicidal foams or prior vasectomy.

STUDY OBJECTIVES

Primary:

• Overall Survival

Secondary:

• Toxicity
• Quality of Life
• Time to Progression
• Identification of genetic signature associated with benefit

KEY DATES

Recruitment start date: 30 March 2009
End of Recruitment: 18 November 2011*
6 months Follow-up/End clinical interventions: 18 May 2012*
End of Trial/All local site involvement: 30 September 2012*

*Please note that these dates are subject to change.

Oncology Clinical Trials Office (OCTO)