Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gefitinib (Iressa®) Versus Placebo in Esophageal Cancer Progressing After Chemotherapy
18 Years
N/A
Both
Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer
Trial Information
Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gefitinib (Iressa®) Versus Placebo in Esophageal Cancer Progressing After Chemotherapy
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 gefitinib monotherapy in these patients.
- To assess whether gefitinib vs placebo will have a significant positive or negative
impact upon quality of life of these patients.
- To assess the impact gefitinib vs placebo will have on progression-free survival of
these patients.
OUTLINE: This is a multicenter study.
- Arm A: Patients receive oral gefitinib once daily. Treatment continues in the absence
of disease progression or unacceptable toxicity.
- Arm B: Patients receive oral placebo once daily. Treatment continues in the absence of
disease progression or unacceptable toxicity.
Blood samples are collected for genetic and translational studies. Patient's quality of life
is assessed at baseline and periodically during the study with completion of EORTC Quality
of Life Questionnaire (QLQ-C30) version 3.0.
After completion of study treatment, patients are followed up every 8 weeks.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Time Frame:
4, 8, 12, 16 weeks then every 8 weeks
Safety Issue:
No
Principal Investigator
David Ferry, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
New Cross Hospital
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
CDR0000689080
NCT ID:
NCT01243398
Start Date:
March 2009
Completion Date:
May 2012
Related Keywords:
- Adenocarcinoma of the Gastroesophageal Junction
- Esophageal Cancer
- adenocarcinoma of the gastroesophageal junction
- adenocarcinoma of the esophagus
- squamous cell carcinoma of the esophagus
- recurrent esophageal cancer
- stage IA esophageal cancer
- stage IB esophageal cancer
- stage IIA esophageal cancer
- stage IIB esophageal cancer
- stage IIIA esophageal cancer
- stage IIIB esophageal cancer
- stage IIIC esophageal cancer
- stage IV esophageal cancer
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Esophageal Diseases
- Esophageal Neoplasms
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