Status:
COMPLETED
A Study of Changes in FDG- and FLT-PET Imaging in Patients With Non-Small Cell Lung Cancer Following Treatment With Erlotinib
Lead Sponsor:
Genentech, Inc.
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a single-arm, open-label, multicenter, international pilot study to evaluate changes that occur in 2-deoxy-2-\[18F\]fluoro-D-glucose (FDG)- and 3'-deoxy-3'-\[18F\]fluorothymidine(FLT)-PET (Pos...
Eligibility Criteria
Inclusion
- Signed Informed Consent Form(s)
- Histologically confirmed NSCLC
- Recurrent or progressive disease after receiving at least one chemotherapy regimen for advanced or metastatic NSCLC
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Age ≥ 18 years
- Recovery from reversible acute effects of prior anti-cancer therapy (chemotherapy, radiotherapy, or investigational treatment) to NCI Common Toxicity Criteria for Adverse Events (NCI CTCAE) Grade ≤ 1 (excluding alopecia)
- Ability to comply with the study and follow-up procedures, including all specified imaging studies
- Ability to take oral medication
- Availability of archival diagnostic paraffin-embedded tumor tissue and willingness to provide sufficient tissue for testing for EGFR levels in tumor by both immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH)
- Life expectancy ≥ 3 months
- Measurable disease on computed tomography (CT)
- At least one detectable lesion on FDG-PET scan and/or FLT-PET scan that is measurable on CT
- Use of an acceptable means of contraception (men and women of childbearing potential) or documentation of infertility
Exclusion
- Prior treatment with an investigational or marketed agent for the purpose of inhibiting epidermal growth factor receptor (EGFR) (including, but not limited to, erlotinib and gefitinib)
- Chemotherapy, radiotherapy, or investigational treatment within 14 days or within 5 half-lives of the active molecules in the chemotherapy or investigational treatment, whichever is longer, prior to study entry or from which patients have not yet recovered
- Inability to take oral medications, disease affecting gastrointestinal absorption, or prior surgical procedure affecting gastrointestinal absorption
- Uncontrolled diabetes
- Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, myocardial infarction within 1 month prior to study entry, hepatic, renal, or metabolic disease)
- Pregnancy or lactation
- History of another malignancy in the past 2 years, unless the malignancy has been adequately treated, is currently not detectable, and is associated with a 5-year survival \> 90%
- Claustrophobia
- Any other disease, condition, physical examination finding, or clinical laboratory finding which, in the opinion of the investigator, makes the patient inappropriate for the study
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2010
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00453362
Start Date
December 1 2006
End Date
April 23 2010
Last Update
March 31 2017
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