Sponsors: University of Oxford & Royal Wolverhampton Hospitals NHS Trust
Funded by: Cancer Research UK The aim of the trial is to investigate the benefits of Iressa® (gefitinib) in halting or slowing the progression of oesophageal cancer after chemotherapy.
Randomised phase III trial of gefitinib 500mg once daily versus placebo in oesophageal cancer progressing after chemotherapy.
Closed to recruitment.
COG has reached its target of 450 patients.
Number of active sites: 51 (October 2011)
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)
- 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.
- Overall Survival
- Quality of Life
- Time to Progression
- Identification of genetic signature associated with benefit
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.