Gefitinib in Treating Patients With Esophageal Cancer That is Progressing After Chemotherapy

University of Oxford

Status and phase

Completed

Phase 3

Conditions

Esophageal Cancer

Adenocarcinoma of the Gastroesophageal Junction

Treatments

Procedure: quality-of-life assessment

Study type

Interventional

Funder types

Other

Identifiers

NCT01243398

UO-COG

CDR0000689080

EU-21085

ISRCTN-29580179

EUDRACT-2007-005391-13

OXFORD-COG

AZ-D7913L00059

Details and patient eligibility

About

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.

Full 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.

Enrollment

450 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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