A Phase 2 interventional study of OSI-774 and Bevacizumab in Kidney Cancer, sponsored by SCRI Development Innovations, LLC. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-01.
Sponsored by SCRI Development Innovations, LLC · Phase 2, Interventional, and Treatment
In this phase II trial, we plan to evaluate the combination of Tarceva and Avastin in the treatment of patients with metastatic renal cell carcinoma. This trial will be one of the first phase II trials to evaluate a combination of targeted agents in the treatment of a common solid tumor with a strong biologic rationale based on Cancer Biology (VHL/HIF/VEGF/EGFr).
Upon determination of eligibility, all patients will receive:
Tarceva + Avastin
1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.
This study's enrollment of 63 is above the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →SCRI Development Innovations, LLC is the lead sponsor of 174 studies on the registry; 5 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 15 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
To be included in this study, you must meet the following criteria:
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
OSI-774 (Tarceva) 150mb PO, days 1-28; bevacizumab (Avastin) 10mg/kg, IV infusion, days 1 and 15; Regimen will be repeated every 28 days.
Drug: OSI-774 · Drug: Bevacizumab
150mg PO, days 1-28, cycle repeated every 28 days
Also known as: Tarceva
10mg/kg, IV infusion, Days 1 and 15, 28 day cycles
Also known as: Avastin
Efficacy of the combination of Tarceva and Avastin
Time frame: 18 months
Objective response rate
Time frame: 18 months
Progression-free survival
Time frame: 18 months
Overall Survival
Time frame: 18 months
Overall tolerability and toxicity of this combination regimen
Time frame: 18 months
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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SCRI Development Innovations, LLC