ABT-510 and Bevacizumab in Treating Patients With Advanced Solid Tumors
RATIONALE: ABT-510 and bevacizumab may stop the growth of solid tumors by blocking blood flow to the tumor. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Giving ABT-510 together with bevacizumab may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of ABT-510 and bevacizumab in treating patients with advanced solid tumors.
Unspecified Adult Solid Tumor, Protocol Specific
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study of ABT-510 in Combination With Bevacizumab in Advanced Solid Tumors|
|Study Start Date:||May 2005|
- Determine the recommended phase II dose for the combination of ABT-510 plus bevacizumab in patients with advanced solid tumors.
- Evaluate dose-limiting toxicities and non dose-limiting toxicities of this combination.
- Collect preliminary data on the clinical activity of this combination (tumor response rate, progression-free survival, and rate of stable disease > 6 months).
OUTLINE: This is a dose-escalation study. Patients are sequentially enrolled with the first 9-18 patients assigned to part 1 and the next 20 patients assigned to part 2 of the study.
- Part 1: Patients receive ABT-510 subcutaneously (SC) twice daily on days 1-28 and bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of patients receive escalating doses of ABT-510 and bevacizumab until the recommended phase II dose is determined. Patients in part 2 are treated at the recommenced phase II dose.
Part 2: The first 10 patients are assigned to group 1. The next 10 patients are assigned to group 2.
- Group 1: Patients receive ABT-510 SC twice daily beginning on day 1 and bevacizumab IV once every 14 days beginning on day 15.
- Group 2: Patients receive ABT-510 SC twice daily beginning on day 15 and bevacizumab IV once every 14 days beginning on day 1.
In both groups, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study.
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Herbert I. Hurwitz, MD||Duke Cancer Institute|