Clinical trial · Observational
Hormone Changes in Women With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Receiving Erlotinib
Evaluation of Hormonal Changes in Women on Erlotinib Therapy
NCT00602433CI-TRIAL-00004689completedClinicalTrials.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)
Studying samples of blood in the laboratory from patients receiving erlotinib may help doctors learn more about the effects of erlotinib on hormone levels. This clinical trial is looking at hormone changes in women with stage IIIB or stage IV non-small cell lung cancer receiving erlotinib.
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 |
|---|---|---|---|
| Advanced Nonsmall Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- questionnaire and laboratory biomarker analysis
- description
- Subjects with advanced non-small cell lung cancer and take erlotinib as part of their anticancer therapy for at least 3 months. Subjects have had some changes in hair growth, acne or menses (periods) that might be a side effect of erlotinib. Subjects will complete a questionnaire and blood collected for biomarker analysis.
Primary outcomes (1)
- measure
- Presence of hyperandrogenemia
- timeFrame
- One approximate 30 minute visit
- description
- We will determine if hyperandrogenemia is present in women with nonsmall cell lung cancer who are taking erlotinib.
Secondary outcomes (2)
- measure
- Dermatologic manifestations
- timeFrame
- One approximate 30 minute visit
- description
- We will describe the dermatologic manifestations of erlotinib in women
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
* Histologically confirmed non-small cell lung cancer * Stage IIIB (effusion) or stage IV disease * Must be receiving daily erlotinib hydrochloride for more than 3 months * Must have hirsutism, acne, androgenic alopecia, amenorrhea, truncal weight gain, or other clinical phenotype associated with syndrome of androgen excess
References
Publications (0)
Data not yet available
No reference posted for this study.