Status:
UNKNOWN
The Role of Positron Emission Tomography (PET) During Erlotinib Treatment for Non-small Cell Lung Cancer
Lead Sponsor:
Asan Medical Center
Conditions:
Erlotinib
Lung Cancer
Eligibility:
All Genders
18-85 years
Brief Summary
Erlotinib is an inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase. Higher response rates were observed in a subset of patients with female gender, Asian ethnicity, no smoking hi...
Detailed Description
1. Primary objectives: To see whether the % change in SUVmax of a tumor with FLT-PET or FDG-PET at 7 days after initiating erlotinib treatment compared with baseline SUVmax (ΔSUVmax) would predict...
Eligibility Criteria
Inclusion
- \> 18 years of age
- Histologically documented non-small cell lung cancer with metastasis (Stage IV) or locally advanced (Stage IIIB) with malignant effusion.
- At least 1 measurable lesion as defined by RECIST. All target lesions must have a unidirectional diameter of at least 1cm. Baseline measurements must be compared within 4 weeks prior to enrollment.
- ECOG PS 0-2
- At least 3 weeks since the 1st line systemic therapy regimen prior to enrollment. Patients must have recovered to NCI CTCAE v3.0 grade I from all toxicities. But 1st line erlotinib treatment is also allowed.
- At least 1 week since the last radiotherapy. Patients must have recovered from all acute toxicities from radiotherapy.
- Patients must have adequate hematologic, renal and liver function as defined by Hb \> 9g/dL, neutrophils \> 1000/mm3, platelets \> 50,000/mm3, creatinine \< 2mg/dL, and AST (SGOT) and/or ALT (SGPT) \< 5 x UNL (upper normal limit).
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
- Written and voluntary informed consent understood, signed and dated.
Exclusion
- Prior EGFR TKI treatment.
- Symptomatic brain metastasis. Brain metastases stable \< 2 weeks before dosing or requiring concurrent steroid treatment or with clinical symptoms.
- Major surgery within 3 weeks prior to study enrollment.
- Previous (less than 3 years ago) or current malignancies at sites other than curatively treated in situ carcinoma of cervix, or basal or squamous cell carcinoma of the skin.
- Severe medical illness or active infection that would impair the ability to receive erlotinib.
- Pregnancy or breast feeding.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01000428
Start Date
June 1 2009
End Date
December 1 2011
Last Update
October 27 2009
Active Locations (1)
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1
Asan Medical Center
Seoul, SongPa-Gu, South Korea