Clinical trial NCT00193154: OSI-774 and Bevacizumab in the Treatment of Patients With Metastatic Renal Cell Carcinoma
Official title: A Phase II Trial of Tarceva (OSI-774) and Avastin (Bevacizumab) in the Treatment of Patients With Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Cancer
Keywords: Kidney Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Genentech, Inc.
First posted: 2005-09-19
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: Upon determination of eligibility, all patients will receive:

Tarceva + Avastin

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of the combination of Tarceva and Avastin
timeFrame: 18 months
Secondary outcomes:
measure: Objective response rate
timeFrame: 18 months
measure: Progression-free survival
timeFrame: 18 months
measure: Overall Survival
timeFrame: 18 months
measure: Overall tolerability and toxicity of this combination regimen
timeFrame: 18 months
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Medical Oncology LLC
state: Louisiana
city: Grand Rapids
country: United States
facility: Grand Rapids Oncology Program
state: Michigan
Study officials:
affiliation: SCRI Development Innovations, LLC
name: John D. Hainsworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.