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| Sponsor: | Case Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Case Comprehensive Cancer Center |
| 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 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Pharmacokinetic Trial of Thalidomide and Docetaxel: A Regimen Based on Anti-Angiogenic Therapeutic Principles |
| Enrollment: | 26 |
| Study Start Date: | July 2002 |
| Study Completion Date: | January 2006 |
| Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
Patients receive 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.
Patients receive oral thalidomide twice daily. 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.
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 Case Medical Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Principal Investigator: | Scot C. Remick, MD | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
More Information
| Responsible Party: | Scot C. Remick, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00049296 History of Changes |
| Other Study ID Numbers: | CWRU4Y01, P30CA043703, CWRU-4Y01, NCI-G02-2123 |
| Study First Received: | November 12, 2002 |
| Last Updated: | June 10, 2010 |
| Health Authority: | United States: Federal Government |
|
adult anaplastic astrocytoma male breast cancer adult anaplastic oligodendroglioma adult meningeal hemangiopericytoma adult brain stem glioma adult central nervous system germ cell tumor adult choroid plexus tumor adult craniopharyngioma adult ependymoblastoma adult glioblastoma adult pilocytic astrocytoma adult anaplastic ependymoma adult medulloblastoma adult meningioma adult pineoblastoma |
adult pineocytoma adult subependymoma adult myxopapillary ependymoma advanced adult primary liver cancer anterior urethral cancer carcinoma of the appendix chondrosarcoma classic Kaposi sarcoma AIDS-related Kaposi sarcoma immunosuppressive treatment related Kaposi sarcoma recurrent Kaposi sarcoma clear cell sarcoma of the kidney disseminated neuroblastoma extensive stage small cell lung cancer gastrointestinal stromal tumor |
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Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Immunoblastic Neuroectodermal Tumors, Primitive, Peripheral Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Thalidomide Docetaxel Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |