The Role of Positron Emission Tomography (PET) During Erlotinib Treatment for Non-small Cell Lung Cancer

NCT01000428 | Unknown

• 1 other identifier: AMC-2008-0511
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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 history, mutations in EGFR tyrosine kinase, high EGFR gene copy number and adenocarcinoma histology. However, the therapeutic effect of Erlotinib is not confined to patients whose tumors harbor EGFR mutations and other predictors of efficacy of this agent. And these tests require time and sufficiently large specimens for processing, whereas many patients with advanced NSCLC are diagnosed based on cytology alone. This study was designed to evaluate FLT-PET or FDG-PET usefulness in the early assessment of treatment response and in predicting patient outcome after erlotinib monotherapy for patients with non-small cell lung cancer prospectively. Changes in tumor FLT or FDG uptake 7 days after the initiation of treatment will be compared between responders and nonresponders based on subsequent CT scans.

Conditions

Erlotinib; Lung Cancer

Keywords

NSCLC; Tarceva; Positron emission technology; FLT; FDG

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Histologically documented non-small cell lung cancer with metastasis (Stage IV) or locally advanced (Stage IIIB) with malignant effusion.

You may qualify if:

• \> 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, SongPa-Gu, South Korea

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Sang-We Kim, M.D.

CONTACT

82-2-3010-3215; swkim@amc.seoul.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 22, 2009
• First Posted: October 23, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: December 1, 2011
• Last Updated: October 27, 2009

Record last verified: 2009-10

Locations

KR (1)