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| Sponsors and Collaborators: |
Ireland Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00049296 |
Purpose
RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining thalidomide with docetaxel may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining thalidomide with docetaxel in treating patients who have advanced cancer.
| Condition | Intervention | Phase |
|
Cancer |
Drug: docetaxel Drug: thalidomide |
Phase I |
| Genetics Home Reference related topics: | bladder cancer breast cancer |
| MedlinePlus related topics: | Cancer Carcinoid Tumors Esophageal Cancer Esophagus Disorders Kaposi's Sarcoma Lung Cancer Lymphoma Pancreatic Cancer Soft Tissue Sarcoma |
| Drug Information available for: | Docetaxel Thalidomide Salicylsalicylic acid Sodium salicylate |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Pharmacokinetic Trial of Thalidomide and Docetaxel: A Regimen Based on Anti-Angiogenic Therapeutic Principles |
| Study Start Date: | July 2002 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive oral thalidomide twice daily and docetaxel IV over 30 minutes once weekly. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of docetaxel and thalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 3-30 patients 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:
Tumor types may include any of the following:
Primary CNS neoplasms if the following are true:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Ohio | |||||
| Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | |||||
| Cleveland, Ohio, United States, 44106-5065 | |||||
| Ireland Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Scot C. Remick, MD | Case Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000258044, CWRU-4Y01, NCI-G02-2123 |
| First Received: | November 12, 2002 |
| Last Updated: | November 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00049296 |
| Health Authority: | United States: Federal Government |
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