Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00126503 |
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab and sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with bevacizumab may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of sorafenib and bevacizumab and to see how well they work in treating patients with advanced kidney cancer.
Condition | Intervention | Phase |
---|---|---|
Kidney Cancer |
Drug: bevacizumab Drug: sorafenib tosylate |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Trial of BAY 43-9006 in Combination With Bevacizumab in Patients With Advanced Renal Cell Cancer |
Estimated Enrollment: | 58 |
Study Start Date: | May 2005 |
Estimated Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter, phase I dose-escalation study followed by a phase II study.
Cohorts of 3-6 patients receive escalating doses of sorafenib and bevacizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.
NOTE: *Patients may remain on protocol if only 1 of the drugs is stopped.
PROJECTED ACCRUAL: A total of 32-58 patients (12-18 for the phase I portion and 20-40 for the phase II portion) will be accrued for this study within approximately 5-19 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed renal cell carcinoma (RCC) of 1 of the following types*:
Has undergone prior nephrectomy, unless 1 of the following is true (for patients in the phase II portion of the study only):
No history or clinical evidence of CNS disease, including primary brain tumor (history of meningioma allowed), or brain metastasis
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No uncontrolled hypertension
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No prior chemotherapy regimen for stage IV disease (for patients in the phase II portion of the study only)
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent or recent (within 7 days of starting study drugs) use of full-dose anticoagulants or thrombolytic agents
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Clinical Trials Office - Beth Israel Deaconess Medical Center 617-667-9925 | |
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers 800-474-9892 | |
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center - Cool Springs | Recruiting |
Nashville, Tennessee, United States, 37064 | |
Contact: Jeffrey A. Sosman 615-936-3048 | |
Vanderbilt-Ingram Cancer Center at Franklin | Recruiting |
Nashville, Tennessee, United States, 37064 | |
Contact: Jeffrey A. Sosman 615-936-3048 | |
Vanderbilt-Ingram Cancer Center | Recruiting |
Nashville, Tennessee, United States, 37232-6838 | |
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 |
Study Chair: | Jeffrey A. Sosman, MD | Vanderbilt-Ingram Cancer Center |
Study ID Numbers: | CDR0000434814, VICC-URO-0470, NCI-6555 |
Study First Received: | August 2, 2005 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00126503 |
Health Authority: | Unspecified |
clear cell renal cell carcinoma recurrent renal cell cancer stage IV renal cell cancer |
Urogenital Neoplasms Bevacizumab Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma Urologic Diseases |
Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Clear cell renal cell carcinoma Sorafenib Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Angiogenesis Inhibitors |
Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |