Status:
COMPLETED
Gefitinib in Treating Patients With Esophageal Cancer That is Progressing After Chemotherapy
Lead Sponsor:
University of Oxford
Conditions:
Adenocarcinoma of the Gastroesophageal Junction
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether gefitinib is more ef...
Detailed Description
OBJECTIVES: Primary * To assess whether gefitinib vs placebo will improve overall survival of patients with esophageal or gastroesophageal junction cancer. Secondary * To assess the toxicity of ge...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed esophageal cancer or gastroesophageal junction tumor including the following subtypes:
- Adenocarcinoma
- Squamous cell cancer
- Poorly differentiated epithelial malignancy
- Gastroesophageal junction with Siewert type I or II tumors
- Failure after no more than 2 prior chemotherapy regimens and 1 chemoradiation course
- Measurable or evaluable disease by CT scan
- Patients with brain metastases must be stable and have received cranial irradiation prior to entry
- PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Serum bilirubin ≤ 3 times the upper limit of normal (ULN)
- AST/ALT ≤ 2.5 times ULN (≤ 5 x in presence of liver metastases)
- Able to take oral tablets (whole or dispersed)
- No evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic allowed)
- No known severe hypersensitivity to gefitinib or any of the excipients of this product
- No prior other malignancy likely to confound results or interfere with gefitinib therapy
- No medical condition considered to interfere with the safe participation in the trial
- Not pregnant
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No chemotherapy (including oral) within the past 6 weeks
- No radiotherapy to site of measurable or evaluable disease within the past 4 weeks
- No other concurrent cytotoxic chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids) or experimental medications
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT01243398
Start Date
March 1 2009
End Date
May 1 2012
Last Update
November 29 2012
Active Locations (1)
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1
New Cross Hospital
Wolverhampton, England, United Kingdom, WV10 0QP