Gefitinib in Treating Patients With Esophageal Cancer That is Progressing After Chemotherapy
This study has been completed.
Sponsor:
University of Oxford
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01243398
First received: November 17, 2010
Last updated: November 28, 2012
Last verified: November 2012
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Purpose
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 effective than a placebo in treating esophageal cancer.
PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works compared with a placebo in treating patients with esophageal cancer that is progressing after chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Adenocarcinoma of the Gastroesophageal Junction Esophageal Cancer |
Procedure: quality-of-life assessment |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gefitinib (Iressa®) Versus Placebo in Esophageal Cancer Progressing After Chemotherapy |
Resource links provided by NLM:
Further study details as provided by University of Oxford:
Primary Outcome Measures:
- Overall survival [ Time Frame: 4, 8, 12, 16 weeks then every 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity and safety [ Time Frame: 4, 8, 12, 16 weeks then every 8 weeks ] [ Designated as safety issue: Yes ]
- Quality of life [ Time Frame: 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 4, 8, 12, 16 weeks then every 8 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 450 |
| Study Start Date: | March 2009 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Gefitinib 500mg once daily
Gefitinib 500mg once daily
|
Procedure: quality-of-life assessment |
|
Placebo Comparator: Placebo
Gefitinib 500mg once daily
|
Procedure: quality-of-life assessment |
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | University of Oxford |
| ClinicalTrials.gov Identifier: | NCT01243398 History of Changes |
| Other Study ID Numbers: | CDR0000689080, OXFORD-COG, UO-COG, EUDRACT-2007-005391-13, ISRCTN-29580179, AZ-D7913L00059, EU-21085 |
| Study First Received: | November 17, 2010 |
| Last Updated: | November 28, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by University of Oxford:
|
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 |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Esophageal Diseases Esophageal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Gastrointestinal Diseases Digestive System Diseases |
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms Gefitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013