Clinical trial · Interventional
Study Evaluating the Addition of Fulvestrant to Erlotinib in Stage IIIB/IV Non-Small Cell Lung Cancer
Phase II Trial Evaluating Addition of Fulvestrant to Erlotinib in Patients With Stage IIIB/IV NSCLC Who Are Stable on Erlotinib and Exhibit Positivity for Estrogen or Progesterone Receptor
NCT00592007CI-TRIAL-00028003terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was terminated due to slow subject accrual
Summary
Brief summary (as posted)
The main purpose of this research study is to see if adding fulvestrant (Faslodex) to erlotinib (Tarceva) is effective in patients with stage IIIb/IV Non-Small Cell Lung Cancer.
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 |
|---|---|---|---|
| Non Small Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fulvestrant and Erlotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- description
- Single-arm study
- interventionNames
- Drug: Fulvestrant and Erlotinib
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- 14 weeks after start of fulvestrant
Secondary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Patients will be followed until death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Estrogen or progesterone receptor positive stage IIIb/IV non-small cell lung cancer * Eligible patients will have stable disease on erlotinib monotherapy at FDA- approved doses after a minimum duration of erlotinib therapy of 2 months * 18 years or older * ECOG Performance Status ≤2 * Adequate Organ Function Requirements * Adequate coagulation function * Postmenopausal status in female patients is required and is defined as no menstrual periods for 12 month or surgical menopause * All patients must sign a written informed consent. Exclusion Criteria: * Pregnant or breast-feeding women will not be entered on this study * Patients who are currently receiving another investigational drugs * Patients who are currently receiving other anti-cancer agents. * Hormone replacement therapy will not be allowed and have to be stopped 1 month prior to entry into the study * Patients who have an uncontrolled infection. * Patients receiving less than 100mg/day of erlotinib * Patients with evidence of progression after 2 months of erlotinib monotherapy. * Patients with a history of bleeding diathesis (i.e., disseminated intravascular coagulation \[DIC\], clotting factor deficiency) or long-term anticoagulant therapy (other than antiplatelet therapy). * Patients with a history of hypersensitivity to active or inactive excipients of fulvestrant (i.e. castor oil or Mannitol). * Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.