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

Primary Purpose

Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer

Status

Completed

Phase

Phase 3

Locations

United Kingdom

Study Type

Interventional

Intervention

quality-of-life assessment

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Gastroesophageal Junction focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gefitinib 500mg once daily

Placebo

Arm Description

Gefitinib 500mg once daily

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Toxicity and safety

Quality of life

Progression-free survival

Full Information

NCT ID

NCT01243398

First Posted

November 17, 2010

Last Updated

November 28, 2012

Sponsor

University of Oxford

1. Study Identification

Unique Protocol Identification Number

NCT01243398

Brief Title

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

Official Title

Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gefitinib (Iressa®) Versus Placebo in Esophageal Cancer Progressing After Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oxford

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

450 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gefitinib 500mg once daily

Arm Type

Experimental

Arm Description

Gefitinib 500mg once daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Gefitinib 500mg once daily

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

Primary Outcome Measure Information:

Title

Overall survival

Time Frame

4, 8, 12, 16 weeks then every 8 weeks

Secondary Outcome Measure Information:

Title

Toxicity and safety

Time Frame

4, 8, 12, 16 weeks then every 8 weeks

Title

Quality of life

Time Frame

4, 8 and 12 weeks

Title

Progression-free survival

Time Frame

4, 8, 12, 16 weeks then every 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Ferry, MD

Organizational Affiliation

New Cross Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

New Cross Hospital

City

Wolverhampton

State/Province

England

ZIP/Postal Code

WV10 0QP

Country

United Kingdom

12. IPD Sharing Statement

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

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