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| ID | Type | Description | Link |
|---|---|---|---|
| AVF2488s |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
| Genentech, Inc. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSI-774 & bevacizumab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OSI-774 | Drug | 150mg PO, days 1-28, cycle repeated every 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the combination of Tarceva and Avastin | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | 18 months | |
| Progression-free survival | 18 months | |
| Overall Survival |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| John D. Hainsworth, MD | SCRI Development Innovations, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Oncology LLC | Baton Rouge | Louisiana | 70809 | United States | ||
| Grand Rapids Oncology Program |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16204015 | Result | Hainsworth JD, Sosman JA, Spigel DR, Edwards DL, Baughman C, Greco A. Treatment of metastatic renal cell carcinoma with a combination of bevacizumab and erlotinib. J Clin Oncol. 2005 Nov 1;23(31):7889-96. doi: 10.1200/JCO.2005.01.8234. Epub 2005 Oct 3. |
| Label | URL |
|---|---|
| Published article in the Journal of Clinical Oncology | View source |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Bevacizumab | Drug | 10mg/kg, IV infusion, Days 1 and 15, 28 day cycles |
|
|
| 18 months |
| Overall tolerability and toxicity of this combination regimen | 18 months |
| Grand Rapids |
| Michigan |
| 49503 |
| United States |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |