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| Sponsor: | AstraZeneca |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Jonsson Comprehensive Cancer Center |
| Information provided by: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00054093 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. ZD6474 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Randomized phase II trial to compare the effectiveness of different regimens of ZD6474 combined with docetaxel in treating patients who have locally advanced or metastatic non-small cell lung cancer that is refractory to platinum-based chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: docetaxel Drug: vandetanib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Enrollment: | 107 |
| Study Start Date: | November 2002 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter, two-phase study comprising an open-label phase followed by a double-blind, randomized phase.
Randomized phase: Patients are randomized to 1 of 3 treatment arms.
In all arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, after the first 4 courses, and then after every other course thereafter.
Patients are followed at 30 days and then every 6 weeks thereafter.
PROJECTED ACCRUAL: A total of 129 patients (9 patients for the open-label phase, 120 patients [40 per treatment arm] for the randomized phase) will be accrued for this study within approximately 8 months (3 months for the open-label phase, 5 months for the randomized phase).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer
At least one unidimensionally measurable lesion
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
More than 2 weeks since prior, and no concurrent, treatment with any of the following:
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095 | |
| Principal Investigator: | Diane Prager, MD | Jonsson Comprehensive Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00054093 History of Changes |
| Other Study ID Numbers: | D4200C00006, UCLA-0208009, ZENECA-6474IL/0006, CDR0000269881 |
| Study First Received: | February 5, 2003 |
| Last Updated: | April 7, 2011 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
|
stage IIIB non-small cell lung cancer recurrent non-small cell lung cancer stage IIIA non-small cell lung cancer stage IV non-small cell lung cancer stage II non-small cell lung cancer |
stage I non-small cell lung cancer squamous cell lung cancer large cell lung cancer adenocarcinoma of the lung adenosquamous cell lung cancer |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |