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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase I Study of Everolimus and Vatalanib in Patients With Advanced Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Biomarker/Laboratory analysis, Treatment	Active	18 and over	NCI	MAYO-MC0414 MC0414, NCT00655655

Trial Description

Purpose:

Everolimus and vatalanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving everolimus together with vatalanib may kill more tumor cells.

This phase I trial is studying the side effects and best dose of everolimus and vatalanib in treating patients with advanced solid tumors.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Tumor cannot be removed by surgery
• No lymphoma or CNS metastases
• More than 3 weeks since chemotherapy
• More than 2 weeks since biological therapy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive vatalanib by mouth once or twice a day for 4 weeks and everolimus by mouth once a day in weeks 3 and 4. They will then receive vatalanib by mouth once or twice a day and everolimus by mouth once a day for as long as benefit is shown. Some patients may also receive everolimus alone once a day for 2 weeks before beginning vatalanib.

Some patients will undergo blood and tissue sample collection periodically for laboratory studies. Some patients will also undergo ultrasound and MRI.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Mayo Clinic Cancer Center

Julian Molina, MD, PhD, Protocol chair		Ph: 507-284-2511 Email: molina.julian@mayo.edu

U.S.A.
Minnesota
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623

Registry Information
Official Title		A Phase I Trial of the mTOR Inhibitor RAD001 in Combination with VEGF Receptor Tyrosine Kinase Inhibitor PTK787/ZK 222584 in Patients with Advanced Solid Tumors
Trial Start Date		2004-12-01
Trial Completion Date		2009-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00655655
Date Submitted to PDQ		2008-03-26
Information Last Verified		2008-12-28
NCI Grant/Contract Number		CA15083