NCT01243398

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

November 29, 2012

Status Verified

November 1, 2012

Enrollment Period

3.2 years

First QC Date

November 17, 2010

Last Update Submit

November 28, 2012

Conditions

Adenocarcinoma of the Gastroesophageal JunctionEsophageal Cancer

Keywords

adenocarcinoma of the gastroesophageal junctionadenocarcinoma of the esophagussquamous cell carcinoma of the esophagusrecurrent esophageal cancerstage IA esophageal cancerstage IB esophageal cancerstage IIA esophageal cancerstage IIB esophageal cancerstage IIIA esophageal cancerstage IIIB esophageal cancerstage IIIC esophageal cancerstage IV esophageal cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

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

Secondary Outcomes (3)

  • Toxicity and safety

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

  • Quality of life

    4, 8 and 12 weeks

  • Progression-free survival

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

Study Arms (2)

Gefitinib 500mg once daily

EXPERIMENTAL

Gefitinib 500mg once daily

Procedure: quality-of-life assessment

Placebo

PLACEBO COMPARATOR

Gefitinib 500mg once daily

Procedure: quality-of-life assessment

Interventions

quality-of-life assessmentPROCEDURE
Gefitinib 500mg once dailyPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

New Cross Hospital

Wolverhampton, England, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Esophageal NeoplasmsAdenocarcinoma Of EsophagusEsophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Study Officials

  • David Ferry, MD

    New Cross Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2010

First Posted

November 18, 2010

Study Start

March 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

November 29, 2012

Record last verified: 2012-11

Locations

GB(1)