Thalidomide and Docetaxel in Treating Patients With Advanced Cancer
NCT00049296 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2010-06-11
Summary
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.
Conditions
Interventions
- DRUG
-
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.
- DRUG
-
thalidomide
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.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Case Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
Scot C. Remick, MD · Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-07-31
- Primary Completion
- 2004-12-31
- Completion
- 2006-01-31
Countries
- United States
Study Locations
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