Bortezomib and Topotecan in Treating Patients With Advanced Solid Tumors
NCT00388089 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2010-06-29
Summary
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with topotecan may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib and topotecan in treating patients with advanced solid tumors.
Conditions
- Lung Cancer
- Unspecified Adult Solid Tumor, Protocol Specific
Interventions
- DRUG
-
Dose level A: 1 mg/m2; Dose level B: 1.3 mg/m2; Dose level C: 1.6 mg/m2; Dose level D: 1.6 mg/m2
- DRUG
-
topotecan hydrochloride
Dose level A: 3 mg/m2; Dose level B: 3 mg/m2; Dose level C: 3 mg/m2; Dose level D: 4 mg/m2
- OTHER
-
flow cytometry
No description
- OTHER
-
immunoenzyme technique
No description
- OTHER
-
immunohistochemistry staining method
No description
- OTHER
-
laboratory biomarker analysis
No description
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
University of California, Davis
lead OTHER
Principal Investigators
-
Angela Davies, MD · University of California, Davis
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-12-31
- Primary Completion
- 2007-11-30
- Completion
- 2008-06-30
Countries
- United States
Study Locations
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