Clinical trial · Interventional
Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction
Phase I Study of OSI-774 (NSC 718781) for Solid Tumors in Patients With Hepatic or Renal Dysfunction
NCT00030498CI-TRIAL-00008928completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (86)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Anaplastic Astrocytoma | Adult Anaplastic Astrocytoma | ONTOLOGY_EXACT | 0.98 |
| Adult Anaplastic Ependymoma | Adult Anaplastic Ependymoma | ONTOLOGY_EXACT | 0.98 |
| Adult Anaplastic Oligodendroglioma | Adult Anaplastic Oligodendroglioma | ONTOLOGY_EXACT | 0.98 |
| Adult Brain Stem Glioma | Adult Brain Stem Glioma | ONTOLOGY_EXACT | 0.98 |
| Adult Diffuse Astrocytoma | Adult Diffuse Astrocytoma | ONTOLOGY_EXACT | 0.98 |
| Adult Ependymoblastoma | Adult Embryonal Tumor with Multilayered Rosettes, C19MC-Altered | ALIAS | 0.90 |
| Adult Giant Cell Glioblastoma | Adult Giant Cell Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Adult Glioblastoma | Adult Glioblastoma | ONTOLOGY_EXACT |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (erlotinib hydrochloride)
- description
- Patients receive oral erlotinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: erlotinib hydrochloride
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD) of OSI-774 determined by dose-limiting toxicities
- timeFrame
- Within the first 4 weeks treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 syndrome) * No prior congenital abnormality (e.g., Fuch's dystrophy) * No prior abnormal slit-lamp exam using a vital dye (e.g., fluorescein or Bengal-Rose) * No prior abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test) * No other concurrent uncontrolled illness * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * Not pregnant or nursing * Fertile patients must use effective contraception * No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) * At least 4 weeks since prior chemotherapy (6 weeks for melphalan or mitomycin) * No prior nitrosoureas * See Disease Characteristics * No concurrent steroids * At least 4 weeks since prior radiotherapy * At least 4 weeks since prior major surgery * No prior surgical procedures affecting absorption * No prior EGFR-targeting therapies, including gefitinib or Imclone C-225 * At least 3 months since prior suramin * More than 7 days since prior grapefruit juice * More than 7 days since other prior CYP3A4 inhibitors * No concurrent grapefruit juice * No concurrent CYP3A4 inducers, substrates, or other inhibitors * No concurrent medications known to affect hepatic or renal function, including antiseizure medication or nonsteroidal anti-inflammatory agents * No concurrent combination anti-retroviral therapy for HIV-positive patients
References
Publications (0)
Data not yet available
No reference posted for this study.