Effects Of Lapatinib (GW572016) In Patients With Relapsed Adenocarcinoma Of The Esophagus (NCT00259987) | Clinical Trial Compass
CompletedPhase 2
Effects Of Lapatinib (GW572016) In Patients With Relapsed Adenocarcinoma Of The Esophagus
United States, Netherlands, Peru24 participantsStarted 2005-11
Plain-language summary
This Phase II study will assess the efficacy, safety, and pharmacodynamics and pharmacokinetics of 1000 mg and 1500 mg lapatinib administered once daily in patients with relapsed adenocarcinoma of the esophagus, including tumors of the GE junction and gastric cardia.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Has a histologically confirmed adenocarcinoma of the esophagus.
* GE (gastroesophageal) junction or gastric cardia.
* Must be of non-child-bearing potential or is of child-bearing potential.
* Have a negative serum pregnancy test and agree to an approved form of birth control.
* Have an ECOG (Eastern Cooperative Oncology Group) Performance status less than or equal to 2.
* Have a life expectancy of at least 12 weeks.
* Have provided written informed consent.
* Investigator considers patient to be fit for study from lab test results and interview.
Exclusion criteria:
* Pregnant or lactating female.
* Prior resection of the small bowel.
* Received major surgery.
* Received prior radiation therapy to the mediastinum or abdomen.
* Has a known immediate or delayed hypersensitivity reaction.
* Idiosyncrasy to drugs chemically related to the study drug.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate (ORR) of treatment with daily lapatinib at two different doses (1000 mg and 1500 mg per day)