Clinical trial · Observational
Effects of Epidermal Growth Factor Receptor Inhibitor Therapy in the Skin of Cancer Patients
Pilot Study of the Effects of Epidermal Growth Factor Receptor (EGFR) Inhibitors on the EGFR in Skin Lesions
NCT00483457CI-TRIAL-00007934completedClinicalTrials.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)
RATIONALE: Studying samples of tissue and blood in the laboratory from patients with cancer receiving epidermal growth factor receptor (EGFR) inhibitors may help doctors understand the effects of EGFR inhibitor therapy in the skin. PURPOSE: This laboratory study is looking at the effects of EGFR inhibitors in the skin of cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| enzyme inhibitor therapy | Drug | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| protein expression analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Effects of EGFR inhibitors on the EGFR pathway in the skin prior to and after receiving EGFR inhibitors
- timeFrame
- baseline and at 6 weeks
Secondary outcomes (3)
- measure
- Comparison of the effects of EGFR tyrosine kinase inhibitors vs monoclonal antibodies on the EGFR pathway in the skin
- timeFrame
- at 6 weeks
- measure
- Comparison of changes in the EGFR pathway with grade of rash
- timeFrame
- at 6 weeks
- measure
- Comparison of changes in EGFR pathway effectors in the skin with serum TGFα levels as assessed by immunohistochemistry and western blot
- timeFrame
- at 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of a malignancy for which therapy on or off a clinical trial with an inhibitor of the EGFR pathway is under consideration * The therapy under consideration may be monotherapy or combined with other therapies as long as other therapies do not typically cause a rash PATIENT CHARACTERISTICS: * INR ≤ 3.0 (for patients receiving concurrent warfarin) * No severe underlying skin disorder (e.g., toxic epidermal necrolysis or severe dermatitis) that would preclude study treatment * No bleeding diatheses that would preclude safe biopsy * No allergy to lidocaine or similar local anesthetics PRIOR CONCURRENT THERAPY: * See Disease Characteristics
References
Publications (0)
Data not yet available
No reference posted for this study.