![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00093717 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Zoledronate may delay or prevent the formation of bone metastases. It is not yet known whether chemotherapy is more effective with or without zoledronate in treating non-small cell lung cancer and preventing bone metastases.
PURPOSE: This randomized phase II trial is studying docetaxel and carboplatin alone to see how well it works compared to giving docetaxel and carboplatin together with zoledronate in treating patients with unresectable stage IIIB or stage IV non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: carboplatin Drug: docetaxel Drug: zoledronic acid |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | A Prospective, Multicenter, Randomized Phase II Study to Evaluate the Effects of Zometa® in Combination With Taxotere®/Carboplatin in Patients With Stage IIIB/IV Unresectable Non-Small Cell Lung Cancer |
Estimated Enrollment: | 250 |
Study Start Date: | August 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of therapy, patients in arm I who have responding or stable disease are then re-randomized to 1 of 2 arms.
PROJECTED ACCRUAL: Approximately 250 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed non-small cell lung cancer (NSCLC), including squamous cell carcinoma, adenocarcinoma, and large cell carcinoma
Unresectable stage IIIB disease, including patients with pleural effusion
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Alkaline phosphatase and AST/ALT must meet criteria for one of the following:
Renal
Cardiovascular
Pulmonary
Other
No disease with influence on bone metabolism, including any of the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No prior first-line chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095-1781 |
Study Chair: | Robert A. Figlin, MD, FACP | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000389497, UCLA-0405098-01, NOVARTIS-CZO4L44EUS75 |
Study First Received: | October 6, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00093717 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the lung large cell lung cancer squamous cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Zoledronic acid Carboplatin Carcinoma Docetaxel Adenocarcinoma of lung |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |