Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-26 @ 5:46 PM
Study NCT ID:
NCT00953459
Status:
TERMINATED
Last Update Posted:
2018-07-26
First Post:
2009-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sunitinib Malate in Treating Patients With Small Cell Lung Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
Study Overview
Official Title:
Phase II Study of Sunitinib (SU011248) in Patients With Small Cell Lung Cancer Who Are Either Chemo-naïve (Extensive Disease) or Have a "Sensitive" Relapse
Status:
TERMINATED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poorly recruiting
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib malate works in treating patients with small cell lung cancer.
PURPOSE: This phase II trial is studying how well sunitinib malate works in treating patients with small cell lung cancer.
Detailed Description:
OBJECTIVES:
Primary
* To assess the therapeutic activity of sunitinib malate in patients with either chemonaïve extensive stage or sensitive relapsed small cell lung cancer.
Secondary
* To characterize the safety of sunitinib malate in these patients.
Tertiary
* To determine the potential of FDG-PET-scan to serve as a surrogate marker of response for the antiangiogenic activity of the compound.
OUTLINE: This is a multicenter study. Patients are stratified according to disease stage (chemonaïve extensive stage vs sensitive relapse at least 3 months after stopping chemotherapy).
Patients receive oral sunitinib malate once daily for up to 1 year in the absence of disease progression or unacceptable toxicity.
Patients undergo fludeoxyglucose F 18 positron emission tomography of the chest at week 4. Blood samples and bronchial washings and brushings may be collected at baseline and at 4 and 8 weeks after start of therapy for further analysis.
After completion of study treatment, patients are followed up every 3 months.
Primary
* To assess the therapeutic activity of sunitinib malate in patients with either chemonaïve extensive stage or sensitive relapsed small cell lung cancer.
Secondary
* To characterize the safety of sunitinib malate in these patients.
Tertiary
* To determine the potential of FDG-PET-scan to serve as a surrogate marker of response for the antiangiogenic activity of the compound.
OUTLINE: This is a multicenter study. Patients are stratified according to disease stage (chemonaïve extensive stage vs sensitive relapse at least 3 months after stopping chemotherapy).
Patients receive oral sunitinib malate once daily for up to 1 year in the absence of disease progression or unacceptable toxicity.
Patients undergo fludeoxyglucose F 18 positron emission tomography of the chest at week 4. Blood samples and bronchial washings and brushings may be collected at baseline and at 4 and 8 weeks after start of therapy for further analysis.
After completion of study treatment, patients are followed up every 3 months.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: