COG

STUDY STATUS

Open to recruitment.
Target recruitment: 450 patients
Current recruitment: 82 patients (February 2010)
Number of active sites: 36 (February 2010)
 

STUDY SCHEMA

INCLUSION CRITERIA

• Age ≥ 18 years
• Histologically proven adenocarcinoma, squamous cell cancer or poorly differentiated epithelial malignancy
• Oesophageal cancers and type I and type II junctional tumours (see Figure 1)
• Up to two prior regimens, either one as neoadjuvant plus one for advanced disease, or up to two for advanced disease [date of last administration of chemotherapy must be >6 weeks prior to randomisation]
• WHO Performance Status 0, 1 or 2
• Measurable or evaluable disease by CT scan
• Able to swallow tablets
• Patients with brain metastases must be stable and have received cranial irradiation prior to entry

EXCLUSION CRITERIA

• 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
• 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 product
• On other 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

Planned recruitment stop date: 30 September 2010

Planned final analysis: 31 March 2011

Oncology Clinical Trials Office (OCTO)