ZD6474 in Treating Patients With Small Cell Lung Cancer
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.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|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|
- Progression-free survival [ Designated as safety issue: No ]
- Overall Survival [ Designated as safety issue: No ]
- Response rates [ Designated as safety issue: No ]
- Toxicity and safety [ Designated as safety issue: Yes ]
- Pharmacokinetics [ Designated as safety issue: No ]
- Quality of life (QOL) as measured by EORTC QLQ-C30 and QLQ-LC13 [ Designated as safety issue: No ]
|Study Start Date:||May 2003|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066313
|Tom Baker Cancer Centre - Calgary|
|Calgary, Alberta, Canada, T2N 4N2|
|Cross Cancer Institute at University of Alberta|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|British Columbia Cancer Agency - Centre for the Southern Interior|
|Kelowna, British Columbia, Canada, V1Y 5L3|
|Fraser/Valley Cancer Centre at British Columbia Cancer Agency|
|Surrey, British Columbia, Canada, V3V 1Z2|
|British Columbia Cancer Agency - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Canada, New Brunswick|
|Moncton, New Brunswick, Canada, E1C 6ZB|
|Saint John Regional Hospital|
|Saint John, New Brunswick, Canada, E2L 4L2|
|Margaret and Charles Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Centre of Southeastern Ontario at Kingston General Hospital|
|Kingston, Ontario, Canada, K7L 5P9|
|Ottawa Hospital Regional Cancer Centre - General Campus|
|Ottawa, Ontario, Canada, K1H 8L6|
|St. Catharines General Hospital at Niagara Health System|
|St. Catharines, Ontario, Canada, L2R 5K3|
|Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre|
|Thunder Bay, Ontario, Canada, P7B 6V4|
|Toronto East General Hospital|
|Toronto, Ontario, Canada, M4C 3E7|
|Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Mount Sinai Hospital - Toronto|
|Toronto, Ontario, Canada, M5G 1X5|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Windsor Regional Cancer Centre at Windsor Regional Hospital|
|Windsor, Ontario, Canada, N8W 2X3|
|Hopital Notre- Dame du CHUM|
|Montreal, Quebec, Canada, H2L 4M1|
|McGill Cancer Centre at McGill University|
|Montreal, Quebec, Canada, H2W 1S6|
|Ste-Foy, Quebec, Canada, G1V 4G5|
|Saskatoon Cancer Centre at the University of Saskatchewan|
|Saskatoon, Saskatchewan, Canada, S7N 4H4|
|Study Director:||Clinical Sciences & Operations||Sanofi|