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Sponsors and Collaborators: |
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00601926 |
RATIONALE: 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 may also stop the growth of kidney cancer by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying the side effects and how well bevacizumab works in treating patients with unresectable or metastatic kidney cancer.
Condition | Intervention | Phase |
---|---|---|
Kidney Cancer |
Biological: bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A Phase II Trial Of Avastin (Bevacizumab) In Patients With Metastatic Papillary Renal Cell Carcinoma |
Estimated Enrollment: | 41 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed papillary renal cell carcinoma (RCC)
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Proteinuria at screening as demonstrated by either of the following:
PRIOR CONCURRENT THERAPY:
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting |
Columbus, Ohio, United States, 43210-1240 | |
Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 osu@emergingmed.com |
Principal Investigator: | J. Paul Monk, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Responsible Party: | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center ( J. Paul Monk, III ) |
Study ID Numbers: | CDR0000581136, OSU-06111 |
Study First Received: | January 22, 2008 |
Last Updated: | March 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00601926 History of Changes |
Health Authority: | Unspecified |
papillary renal cell carcinoma stage III renal cell cancer stage IV renal cell cancer |
Urinary Tract Neoplasm Kidney Cancer Chromophil Renal Cell Carcinoma Urogenital Neoplasms Bevacizumab Urologic Neoplasms Angiogenesis Inhibitors Carcinoma |
Renal Cancer Papillary Renal Cell Carcinoma Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Physiological Effects of Drugs Urogenital Neoplasms Bevacizumab Urologic Neoplasms Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Carcinoma, Renal Cell Growth Inhibitors Angiogenesis Modulating Agents Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |