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| Sponsor: | AstraZeneca |
|---|---|
| Information provided by: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00066313 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: vandetanib Procedure: adjuvant therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind 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 |
| Study Start Date: | May 2003 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
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| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell carcinoma of the lung
Must have received at least 4 courses of first-line combination chemotherapy as part of an induction regimen
Must have achieved a radiologically confirmed (i.e., CT scan, chest x-ray, or bone scan) complete response (CR) or partial response (PR) after prior chemotherapy with or without radiotherapy AND meets 1 of the following criteria:
No CNS metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No prior ventricular arrhythmia that was symptomatic or required treatment (CTC grade 3), including any of the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
No concurrent anticancer radiotherapy
Surgery
Other
No concurrent CYP3A4 inhibitors or inducers, including any of the following:
No concurrent oral bisphosphonates (e.g., clodronate)
Contacts and Locations| Canada, Alberta | |
| 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 Hospital | |
| Moncton, New Brunswick, Canada, E1C 6ZB | |
| Saint John Regional Hospital | |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Canada, Ontario | |
| 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 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Mount Sinai Hospital - Toronto | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| 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 | |
| Windsor Regional Cancer Centre at Windsor Regional Hospital | |
| Windsor, Ontario, Canada, N8W 2X3 | |
| Canada, Quebec | |
| Hopital Notre- Dame du CHUM | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| McGill Cancer Centre at McGill University | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| L'Hopital Laval | |
| Ste-Foy, Quebec, Canada, G1V 4G5 | |
| Canada, Saskatchewan | |
| Saskatoon Cancer Centre at the University of Saskatchewan | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Study Chair: | Andrew M. Arnold, MD | Margaret and Charles Juravinski Cancer Centre |
More Information
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00066313 History of Changes |
| Other Study ID Numbers: | D4200C00005, CAN-NCIC-BR20, ZENECA-6474IL/0005, CDR0000315518 |
| Study First Received: | August 6, 2003 |
| Last Updated: | April 7, 2011 |
| Health Authority: | United States: Food and Drug Administration; United States: Federal Government |
|
extensive stage small cell lung cancer limited stage small cell lung cancer |
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |