Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction (NCT00030498) | Clinical Trial Compass
CompletedPhase 1
Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction
United States75 participantsStarted 2001-12
Plain-language summary
Phase I trial to study the effectiveness of erlotinib in treating patients who have metastatic or unresectable solid tumors and liver or kidney dysfunction. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor
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:
* Histologically confirmed solid tumor, including gliomas and the following epithelial malignancies:
* Non-small cell lung
* Mesothelioma
* Breast
* Head and neck
* Esophageal
* Pancreatic
* Bladder
* Prostate
* Ovarian
* Anal
* Colorectal carcinoma
* Cervical carcinoma
* Hepatocellular carcinoma
* Metastatic or unresectable disease
* Standard curative or palliative therapy does not exist or is no longer effective
* Epidermal growth factor receptor (EGFR) positive
* Hepatic or renal dysfunction defined as one of the following:
* Direct bilirubin 1.0-7.0 mg/dL with any AST
* Albumin less than 2.5 g/dL
* Creatinine 2.5-5.0 mg/dL
* Brain metastases allowed provided patient is asymptomatic, previously treated, has stable disease for at least 2 months, and is not currently receiving steroid therapy
* Hormone receptor status:
* Not specified
* Male or female
* Performance status - ECOG 0-2
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* See Disease Characteristics
* No evidence of biliary obstruction
* See Disease Characteristics
* No evidence of renal obstruction
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No gastrointestinal tract disease that would preclude ability to take oral medications
* No requirement for IV alimentation
* No active peptic ulcer disease
* No prior corneal abnormalities (e.g., dry eye syndrome or Sjogren's syndrom…
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
Maximum tolerated dose (MTD) of OSI-774 determined by dose-limiting toxicities