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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 |
| 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| Study Chair: | Lionel D. Lewis, MD | Norris Cotton Cancer Center |
More Information
| Study ID Numbers: | CDR0000066631, CLB-9871 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003565 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer stage IIIA breast cancer recurrent breast cancer stage IIIB breast cancer stage IIIC breast cancer recurrent non-small cell lung cancer extensive stage small cell lung cancer recurrent small cell lung cancer stage III bladder cancer recurrent bladder cancer stage IV bladder cancer stage IV nasopharyngeal cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
unspecified adult solid tumor, protocol specific untreated metastatic squamous neck cancer with occult primary recurrent metastatic squamous neck cancer with occult primary pulmonary carcinoid tumor stage III squamous cell carcinoma of the lip and oral cavity stage III basal cell carcinoma of the lip stage III verrucous carcinoma of the oral cavity stage III mucoepidermoid carcinoma of the oral cavity stage III adenoid cystic carcinoma of the oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage IV basal cell carcinoma of the lip stage IV verrucous carcinoma of the oral cavity stage IV mucoepidermoid carcinoma of the oral cavity stage IV adenoid cystic carcinoma of the oral cavity recurrent squamous cell carcinoma of the lip and oral cavity |
|
Thoracic Neoplasms Urinary Tract Neoplasm Laryngeal Carcinoma Urogenital Neoplasms Squamous Cell Carcinoma Urologic Neoplasms Hypopharyngeal Cancer Docetaxel Carcinoma, Adenoid Cystic Urologic Diseases Respiratory Tract Diseases Lung Neoplasms Bladder Neoplasm Papilloma Salivary Gland Diseases |
Breast Diseases Nasopharyngeal Carcinoma Cystocele Skin Diseases Urinary Bladder Diseases Urinary Bladder Neoplasms Breast Neoplasms Carcinoma, Basal Cell Granuloma Recurrence Carcinoma Carcinoma, Small Cell Metastatic Squamous Neck Cancer With Occult Primary Head and Neck Neoplasms Lung Diseases |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Skin Diseases Antineoplastic Agents Urinary Bladder Diseases Urinary Bladder Neoplasms Breast Neoplasms Urogenital Neoplasms Urologic Neoplasms Pharmacologic Actions |
Docetaxel Neoplasms Neoplasms by Site Respiratory Tract Diseases Urologic Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Head and Neck Neoplasms Breast Diseases |