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Center for Global Research Data

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

A Randomized, Open-label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Herceptin/Docetaxel and Herceptin/Docetaxel Alone on Progression-free Survival in Patients With HER2 Positive Locally Recurrent or Metastatic Breast Cancer.
Data Contributor: Roche
Study ID: NCT00391092
Sponsor ID: BO20231

A Placebo-Controlled, Double-Blind, Multicenter, Randomized, Phase II Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT00403403
Sponsor ID: AVF3995g

A Phase III, Multicenter, Randomized, Blinded, Placebo-controlled Trial of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Platinum-sensitive Recurrent Ovary, Primary Peritoneal, or Fallopian Tube Carcinoma
Data Contributor: Roche
Study ID: NCT00434642
Sponsor ID: AVF4095g

An International Multi-centre Open-label 2-arm Phase III Trial of Adjuvant Bevacizumab in “Triple Negative” Breast Cancer.
Data Contributor: Roche
Study ID: NCT00528567
Sponsor ID: BO20289

A Randomized, Open-label Study Comparing the Anti-tumor Effect of Treatment With Tarceva Plus Avastin Versus Chemotherapy Plus Avastin in Patients With Advanced Non-small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT00531960
Sponsor ID: BO20571

A Double-blind, Randomised, Multicenter, Phase III Study of Bevacizumab in Combination With Capecitabine and Cisplatin Versus Placebo in Combination With Capecitabine and Cisplatin, as First-line Therapy in Patients With Advanced Gastric Cancer
Data Contributor: Roche
Study ID: NCT00548548
Sponsor ID: AVF4200g

A Randomized, Open-label Phase III Intergroup Study: Effect of Adding Bevacizumab to Cross Over Fluoropyrimidine Based Chemotherapy (CTx) in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line Standard CTx/Bevacizumab Combination
Data Contributor: Roche
Study ID: NCT00700102
Sponsor ID: ML18147

A Randomized, Open-label Study to Explore the Correlation of Biomarkers With Response Rate in Chemo-naive Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer Who Receive Treatment With Avastin in Addition to Carboplatin-based Chemotherapy
Data Contributor: Roche
Study ID: NCT00700180
Sponsor ID: BO21015

A Randomised, Double-blind Study to Evaluate the Efficacy and Safety of Avastin Plus Roferon Compared With Placebo Plus Roferon on Overall Survival and Tumor Assessment in Nephrectomised Patients With Metastatic Clear Cell Renal Cell Carcinoma
Data Contributor: Roche
Study ID: NCT00738530
Sponsor ID: BO17705

Randomized, Open-Label, Phase 3 Study of Pemetrexed Plus Carboplatin and Bevacizumab Followed by Maintenance Pemetrexed and Bevacizumab Versus Paclitaxel Plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients With Stage IIIB or IV Nonsquamous Non-Small Cell Lung Cancer
Data Contributor: Lilly
Study ID: NCT00762034
Sponsor ID: 9707

An Open Label Study to Assess the Effect of Avastin (Bevacizumab) Combined With First Line Paclitaxel-carboplatin or Second Line Tarceva (Erlotinib) on Progression-free Survival in Non-squamous Non-small Cell Lung Cancer Patients With Asymptomatic Untreated Brain Metastasis
Data Contributor: Roche
Study ID: NCT00800202
Sponsor ID: ML21823

A Randomized, Double-blind Study of the Effect of Avastin Plus Cisplatin and Gemcitabine or Placebo Plus Cisplatin and Gemcitabine on Progression-free Survival in Treatment-naïve Patients With Advanced or Recurrent Non-squamous NSCLC
Data Contributor: Roche
Study ID: NCT00806923
Sponsor ID: BO17704

A Phase I-II Study of BIBF 1120 and FOLFOX Compared to Bevacizumab and FOLFOX in First Line Metastatic Colorectal Cancer Patients
Data Contributor: Boehringer Ingelheim
Study ID: NCT00904839
Sponsor ID: 1199.51

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Trial of Bevacizumab, Temozolomide and Radiotherapy, Followed by Bevacizumab and Temozolomide Versus Placebo, Temozolomide and Radiotherapy Followed by Placebo and Temozolomide in Patients With Newly Diagnosed Glioblastoma
Data Contributor: Roche
Study ID: NCT00943826
Sponsor ID: BO21990

A Study of Pemetrexed Plus Carboplatin Followed by Maintenance Pemetrexed vs Paclitaxel Plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients With Advanced NCSLC of Nonsquamous Histology
Data Contributor: Lilly
Study ID: NCT00948675
Sponsor ID: 13258

AURELIA: A Multi-center, Open-label, Randomised, Two-arm Phase III Trial of the Effect on Progression Free Survival of Bevacizumab Plus Chemotherapy Versus Chemotherapy Alone in Patients With Platinum-resistant, Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Data Contributor: Roche
Study ID: NCT00976911
Sponsor ID: MO22224

A Single-Arm, Phase 2 Trial of Pemetrexed, Cisplatin,and Bevacizumab as Induction, Followed by Pemetrexed and Bevacizumab as Maintenance, in First-Line Treatment of Nonsquamous Advanced NSCLC
Data Contributor: Lilly
Study ID: NCT01004250
Sponsor ID: 13034

A Randomized, Double-blind Study of the Effect of Avastin Plus Gemcitabine and Erlotinib Compared With Placebo Plus Gemcitabine and Erlotinib on Overall Survival in Patients With Metastatic Pancreatic Cancer
Data Contributor: Roche
Study ID: NCT01214720
Sponsor ID: BO17706

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer
Data Contributor: Roche
Study ID: NCT01663727
Sponsor ID: GO25632

Available – Avastin in Addition to Platinum-based Chemotherapy is Indicated for First-lime Treatment of Patients With Locally Advanced, Metastatic or Recurrent Non-small Lung Cancer Other Than Predominantly Squamous Cell Histology
Data Contributor: Roche
Study ID: NCT02596958
Sponsor ID: ML21217

A Phase II, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Administered as Monotherapy or in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma
Data Contributor: Roche
Study ID: NCT01984242
Sponsor ID: WO29074

Update: This data request was withdrawn on 8-Jun-2022 by the researcher.