Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066313
Status:
COMPLETED
Last Update Posted:
2016-08-24
First Post:
2003-08-06
Brief Title:
ZD6474 in Treating Patients With Small Cell Lung Cancer
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase II Study Of ZD6474 Or Placebo In Small Cell Lung Cancer Patients Who Have Complete Or Partial Response To Induction Chemotherapy - Radiation Therapy
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE ZD6474 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth ZD6474 may also stop the growth of small cell lung cancer by blocking blood flow to the tumor
PURPOSE This randomized phase II trial is studying how well ZD6474 works compared to placebo in treating patients with small cell lung cancer that has responded to previous chemotherapy with or without radiation therapy
PURPOSE This randomized phase II trial is studying how well ZD6474 works compared to placebo in treating patients with small cell lung cancer that has responded to previous chemotherapy with or without radiation therapy
Detailed Description:
OBJECTIVES
Compare the progression-free survival of patients with previously treated small cell lung cancer SCLC treated with ZD6474 vs placebo
Compare the response rate of patients treated with these regimens only patients who had measurable disease outside a prior radiation field at study entry
Compare the toxicity and tolerability of these regimens in these patients
Compare the pharmacokinetics of these regimens in these patients
Correlate outcome and response with vascular endothelial growth factor expression and microvessel density in patients treated with these regimens
Compare the quality of life of patients treated with these regimens
Provide a comprehensive tumor plasma and urine bank linked to a clinical database for further study of molecular markers in SCLC
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to participating center timing of prior radiotherapy early before day 1 course 4 of chemotherapy vs late vs no prior radiotherapy stage of disease at diagnosis limited vs extensive and response at study entry complete vs partial Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral ZD6474 daily
Arm II Patients receive oral placebo daily In both arms courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every 4 weeks while on therapy and then every 8 weeks until disease progression
Patients are followed every 8 weeks until disease progression and then every 6 months thereafter
PROJECTED ACCRUAL A total of 100 patients 50 per treatment arm will be accrued for this study
Compare the progression-free survival of patients with previously treated small cell lung cancer SCLC treated with ZD6474 vs placebo
Compare the response rate of patients treated with these regimens only patients who had measurable disease outside a prior radiation field at study entry
Compare the toxicity and tolerability of these regimens in these patients
Compare the pharmacokinetics of these regimens in these patients
Correlate outcome and response with vascular endothelial growth factor expression and microvessel density in patients treated with these regimens
Compare the quality of life of patients treated with these regimens
Provide a comprehensive tumor plasma and urine bank linked to a clinical database for further study of molecular markers in SCLC
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to participating center timing of prior radiotherapy early before day 1 course 4 of chemotherapy vs late vs no prior radiotherapy stage of disease at diagnosis limited vs extensive and response at study entry complete vs partial Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral ZD6474 daily
Arm II Patients receive oral placebo daily In both arms courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every 4 weeks while on therapy and then every 8 weeks until disease progression
Patients are followed every 8 weeks until disease progression and then every 6 months thereafter
PROJECTED ACCRUAL A total of 100 patients 50 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000315518 | OTHER | Ctgov temporary | None |
| CAN-NCIC-BR20 | None | None | None |
| ZENECA-6474IL0005 | None | None | None |