Spots Global Cancer Trial Database for ZD6474 in Treating Patients With Small Cell Lung Cancer
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Trial Identification
Brief Title: ZD6474 in Treating Patients With Small Cell Lung Cancer
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
Study ID: NCT00066313
Conditions
Study Description
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.
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.
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Tom Baker Cancer Centre - Calgary, Calgary, Alberta, Canada
Cross Cancer Institute at University of Alberta, Edmonton, Alberta, Canada
British Columbia Cancer Agency - Centre for the Southern Interior, Kelowna, British Columbia, Canada
Fraser/Valley Cancer Centre at British Columbia Cancer Agency, Surrey, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Cancer Centre, Vancouver, British Columbia, Canada
Moncton Hospital, Moncton, New Brunswick, Canada
Saint John Regional Hospital, Saint John, New Brunswick, Canada
Margaret and Charles Juravinski Cancer Centre, Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, Ontario, Canada
Ottawa Hospital Regional Cancer Centre - General Campus, Ottawa, Ontario, Canada
St. Catharines General Hospital at Niagara Health System, St. Catharines, Ontario, Canada
Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario, Canada
Toronto East General Hospital, Toronto, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre, Toronto, Ontario, Canada
Mount Sinai Hospital - Toronto, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Windsor Regional Cancer Centre at Windsor Regional Hospital, Windsor, Ontario, Canada
Hopital Notre- Dame du CHUM, Montreal, Quebec, Canada
McGill Cancer Centre at McGill University, Montreal, Quebec, Canada
L'Hopital Laval, Ste-Foy, Quebec, Canada
Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon, Saskatchewan, Canada
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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