Vandetanib and Temozolomide in Treating Patients With Advanced Solid Tumors That Cannot Be Removed By Surgery
RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vandetanib together with temozolomide may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vandetanib and temozolomide in treating patients with advanced solid tumors that cannot be removed by surgery.
Unspecified Adult Solid Tumor, Protocol Specific
Other: immunoenzyme technique
Other: laboratory biomarker analysis
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study of ZD6474 and Temozolomide in Patients With Advanced Cancer|
- Maximum tolerated dose of vandetanib and temozolomide [ Designated as safety issue: Yes ]
- Adverse events profile [ Designated as safety issue: Yes ]
- Toxicity profile [ Designated as safety issue: Yes ]
- Response profile [ Designated as safety issue: No ]
- Time until any treatment-related toxicity [ Designated as safety issue: Yes ]
- Time until treatment-related grade 3+ toxicity [ Designated as safety issue: Yes ]
- Time until hematologic nadirs [ Designated as safety issue: No ]
- Time to progression [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
- Correlation of changes in VEGF levels, serum angiogenesis, and circulating endothelial cells with response and dose levels [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Estimated Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
- To determine the maximum tolerated dose of concurrently administered vandetanib and temozolomide in patients with unresectable, advanced solid tumors.
- To describe the toxicity profile of this regimen in these patients.
- To describe the response rate in patients treated with this regimen.
- To describe the effects of therapy on angiogenesis-related translational endpoints.
OUTLINE: Patients receive escalating doses of oral vandetanib once daily on days 1-28 and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and prior to each treatment course for correlative laboratory studies, including evaluation of plasma VEGF levels by ELISA, serum angiogenesis assay, and measurement of circulating endothelial cell populations (CD133, CD34, CD146). Frozen serum and plasma samples are also stored for future research studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00601614
|Study Chair:||Ravi D. Rao, MD, MBBS||Mayo Clinic|
|Investigator:||Svetomir Markovic, MD, PhD||Mayo Clinic|