EVALUATING THE ASSOCIATION BETWEEN PROTEINURIA AND THROMBOSIS AND ITS PREDICTORS IN PATIENTS TREATED WITH BEVACIZUMAB

Lead Investigator: Vivek Sharma, University of Louisville
Title of Proposal Research: EVALUATING THE ASSOCIATION BETWEEN PROTEINURIA AND THROMBOSIS AND ITS PREDICTORS IN PATIENTS TREATED WITH BEVACIZUMAB
Vivli Data Request: 6066
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Proteinurea is known to be associated with an increased risk of blood clots/thrombosis due to loss of proteins in the urine that protect against excessive clotting. Bevacizumab is a targeted agent used in many cancers including colon cancer, lung cancer, kidney cancer and others. Since some of these are rather common cancers, its use on the global level runs into several million patients annually. Bevacizumab is known to cause proteinuria (the presence of abnormal quantities of protein in the urine, which may indicate damage to the kidneys) as a side effect and is also known to increase the risk of blood clots/thrombosis. Until now, no previous study has looked at whether the presence of proteinurea could reliably predict which patients getting bevacizumab may develop blood clots/thrombosis. This study will investigate if there is association between moderate to severe proteinuria and blood clots/thrombotic events in patients who are receiving bevacizumab. We will look at patients who have received bevacizumab on various clinical trials in the past and collect information about proteinurea and development of blood clots/thrombosis in the patients. Additional information including the type of cancer being treated, prior history of blood clots/thrombosis and other cardiovascular risk factors will also be collected. Using appropriate statistical methods detailed under the “Statistical Analysis Plan” section, we will then determine whether there is a strong association between proteinurea and thrombosis in patients receiving bevacizumab. If the thrombotic risk associated with bevacizumab can be identified clinically, it would be a beneficial tool for knowing when to implement prophylaxis to prevent thrombosis in high risk patients. It would thus help to reduce worse outcomes that are associated with blood clots/thrombosis, including venous thromboembolism (VTE) recurrence, major bleeding, and increased mortality rate.

Requested Studies:

A 2×2 Factorial Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) (“XELOX”) With/Without Intravenous Bevacizumab (Q3W) Versus Bolus and Continuous Infusion Fluorouracil/Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) (“FOLFOX-4”) With/Without Intravenous Bevacizumab (Q2W) as First-line Treatment for Patients With Metastatic Colorectal Cancer
Data Contributor: Roche
Study ID: NCT00069095
Sponsor ID: NO16966

A Phase III, Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva (Erlotinib) Compared With Tarceva Alone for Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) After Failure of Standard First-Line Chemotherapy
Data Contributor: Roche
Study ID: NCT00130728
Sponsor ID: OSI3364g

A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Trial Comparing Bevacizumab Therapy With or Without Erlotinib After Completion of Chemotherapy With Bevacizumab for the First-Line Treatment of Locally Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT00257608
Sponsor ID: AVF3671g

A Phase II, Multicenter, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy (Docetaxel or Pemetrexed) or Tarceva (Erlotinib) Compared With Chemotherapy (Docetaxel or Pemetrexed) Alone for Treatment of Recurrent or Refractory Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT00095225
Sponsor ID: OSI2950g

A Randomized, Three Arm Multinational Phase III Study to Investigate Bevacizumab (q3w or q2w) in Combination With Either Intermittent Capecitabine Plus Oxaliplatin (XELOX) (q3w) or Fluorouracil/Leucovorin With Oxaliplatin (FOLFOX-4) Versus FOLFOX-4 Regimen Alone as Adjuvant Chemotherapy in Colon Carcinoma: The AVANT Study
Data Contributor: Roche
Study ID: NCT00112918
Sponsor ID: CDR0000427299

A Multicenter, Phase III, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy Regimens in Subjects With Previously Untreated Metastatic Breast Cancer
Data Contributor: Roche
Study ID: NCT00262067
Sponsor ID: AVF3694g

A Phase III, Multicenter, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy Regimens in Subjects With Previously Treated Metastatic Breast Cancer
Data Contributor: Roche
Study ID: NCT00281697
Sponsor ID: AVF3693g

A Phase II Trial of Bevacizumab in Combination With First- or Second-Line Therapy in Subjects With Treated Brain Metastases Due to Non-Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT00312728
Sponsor ID: AVF3752g

A Randomised, Double Blind, Placebo Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Docetaxel in Comparison With Docetaxel Plus Placebo, as First Line Treatment for Patients With HER2 Negative Metastatic and Locally Recurrent Breast Cancer.
Data Contributor: Roche
Study ID: NCT00333775
Sponsor ID: BO17708

A Phase II, Multicenter, Randomized, Non-Comparative Clinical Trial to Evaluate the Efficacy and Safety of Bevacizumab Alone or in Combination With Irinotecan for Treatment of Glioblastoma Multiforme in First or Second Relapse
Data Contributor: Roche
Study ID: NCT00345163
Sponsor ID: AVF3708g

An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy for Treatment of Metastatic or Locally Advanced and Unresectable Colorectal Cancer and Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Excluding Predominant Squamous Cell Histology)
Data Contributor: Roche
Study ID: NCT00388206
Sponsor ID: AVF3991n