A Randomized, Double-blind, Multicenter, Phase II Study to Assess the Safety, Tolerability, and Efficacy of ZD6474 in Combination With Docetaxel (TAXOTERE™) in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) After Failure of Prior Platinum-based Chemotherapy.
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line
Both
Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line
Trial Information
A Randomized, Double-blind, Multicenter, Phase II Study to Assess the Safety, Tolerability, and Efficacy of ZD6474 in Combination With Docetaxel (TAXOTERE™) in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) After Failure of Prior Platinum-based Chemotherapy.
Inclusion Criteria:
- Histologic or cytologic confirmation of NSCLC (locally advanced or metastatic, IB-IV)
- Failure of first-line platinum-based chemotherapy
Exclusion Criteria:
- Mixed small cell or non-small-cell histology
- Bronchoalveolar carcinoma
- Prior chemotherapy or herbal preparations must be discontinued more than 4 weeks
before the start of study therapy (6 weeks for nitrosoureas, mitomycin and suramin)
- Prior treatment with docetaxel
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Outcome Progression free survival
Principal Investigator
ZD6474 Medical Science Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United States: Food and Drug Administration
Study ID:
6474IL/0006
NCT ID:
NCT00047840
Start Date:
October 2002
Completion Date:
September 2006
Related Keywords:
- Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-Line
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Research Site | Anaheim, California |
| Research Site | Boca Raton, Florida |
| Research Site | Albany, Georgia |
| Research Site | Baton Rouge, Louisiana |
| Research Site | Beverly, Massachusetts |
| Research Site | Battle Kreek, Michigan |
| Research Site | Billings, Montana |
| Research Site | Albany, New York |
| Research Site | Asheville, North Carolina |
| Research Site | Bend, Oregon |
| Research Site | Allentown, Pennsylvania |
| Research Site | Abilene, Texas |
