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 range18 Years
SexALL
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…
What they're measuring
1
Maximum tolerated dose (MTD) of OSI-774 determined by dose-limiting toxicities