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| Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003565 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to compare the effectiveness of docetaxel in treating Caucasian and African American patients who have solid tumors.
| Condition | Intervention | Phase |
|
Bladder Cancer Breast Cancer Head and Neck Cancer Lung Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: docetaxel |
Phase II |
| Genetics Home Reference related topics: | bladder cancer breast cancer |
| MedlinePlus related topics: | Bladder Cancer Breast Cancer Cancer Head and Neck Cancer Lung Cancer Salivary Gland Disorders |
| ChemIDplus related topics: | Docetaxel Salicylsalicylic acid Sodium salicylate |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Study of Population Pharmacokinetics of Docetaxel (Taxotere) in Caucasian and African-American Cancer Patients |
| Estimated Enrollment: | 80 |
| Study Start Date: | September 1998 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive docetaxel IV over 1 hour on day 1. Patients may receive additional courses beginning 21 days after the first docetaxel dose at the discretion of the physician.
PROJECTED ACCRUAL: Approximately 80 patients (40 Caucasian and 40 African American) will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
At least 7 days since prior or concurrent CYP450 inducing drugs:
At least 7 days since prior or concurrent CYP450 3A inhibiting drugs:
Contacts and Locations![]() |
Show 74 Study Locations |
| Cancer and Leukemia Group B |
| National Cancer Institute (NCI) |
| Study Chair: | Lionel D. Lewis, MD | Norris Cotton Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000066631, CLB-9871 |
| First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003565 |
| Health Authority: | United States: Federal Government |
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