Clinical trial · Interventional
OSI-774 and Bevacizumab in the Treatment of Patients With Metastatic Renal Cell Carcinoma
A Phase II Trial of Tarceva (OSI-774) and Avastin (Bevacizumab) in the Treatment of Patients With Metastatic Renal Cell Carcinoma
NCT00193154CI-TRIAL-00014149completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| OSI-774 | Drug | Erlotinib Hydrochloride | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OSI-774 & bevacizumab
- description
- 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.
- interventionNames
- Drug: OSI-774
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Efficacy of the combination of Tarceva and Avastin
- timeFrame
- 18 months
Secondary outcomes (4)
- measure
- Objective response rate
- timeFrame
- 18 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: To be included in this study, you must meet the following criteria: * Metastatic or unresectable clear cell kidney cancer confirmed by biopsy * Previous nephrectomy * Maximum of 1 previous regimen for metastatic disease * Ability to perform activities of daily living with minimal assistance * Measurable disease * Adequate bone marrow, liver and kidney function * Give written informed consent prior to study entry Exclusion Criteria: You cannot participate in this study if any of the following apply to you: * Age \< 18 years * Treatment with more than one previous regimen for metastatic disease * Clinically significant cardiovascular disease * Active brain metastases * History of CNS disease * Clinical history of coughing or vomiting blood. * History of thromboembolic disease. * PEG or G-tube are ineligible. * Current use of full dose anticoagulants or thrombolytic agents * Chronic daily treatment with aspirin or NSAIDS * Any clinical evidence or history of a bleeding or clotting disorder 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.
References
Publications (1)
- RESULTHainsworth 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. PMID 16204015