Trial Summary
What is the purpose of this trial?This phase I trial studies the side effects and best dose of vandetanib and everolimus when given together in treating patients with cancer that has spread to other places in the body. Vandetanib and everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Eligibility Criteria
This trial is for patients with advanced or metastatic cancer that's resistant to standard therapy, relapsed, or without a survival-improving standard option. They must be weeks past prior treatments, have adequate organ/marrow function and agree to use contraception. Exclusions include certain heart conditions, uncontrolled illnesses, pregnancy/lactation, and hypersensitivity to the drugs tested.Inclusion Criteria
It has been over 3 weeks since my last chemotherapy.
My blood counts and kidney and liver functions are within the required ranges.
I am capable of limited self-care and spend more than half of my waking hours out of bed.
Exclusion Criteria
I have a slow heartbeat or heart failure that affects my daily life.
I have a genetic heart condition known as long QT syndrome.
My heart's QT interval is over 500 ms and cannot be corrected.
I do not have any uncontrolled illnesses like infections or asthma.
I have had a stroke in the last 3 months.
Treatment Details
The study tests combining vandetanib and everolimus in patients with widespread cancer. It aims to find the safest dose while observing how these drugs might halt cancer cell growth by inhibiting key enzymes necessary for their proliferation.
1Treatment groups
Experimental Treatment
Group I: Treatment (vandetanib, everolimus)Experimental Treatment4 Interventions
Patients receive vandetanib PO QD and everolimus PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Everolimus is already approved in United States, European Union, United States for the following indications:
🇺🇸 Approved in United States as Afinitor for:
- Advanced renal cell carcinoma
- Subependymal giant cell astrocytoma
- Progressive neuroendocrine tumors of pancreatic origin
- Advanced hormone receptor-positive, HER2-negative breast cancer
- Tuberous sclerosis complex-associated partial-onset seizures
🇪🇺 Approved in European Union as Votubia for:
- Subependymal giant cell astrocytoma
- Renal angiomyolipoma
- Tuberous sclerosis complex-associated partial-onset seizures
🇺🇸 Approved in United States as Zortress for:
- Prevention of organ rejection in kidney transplant patients
Find a clinic near you
Research locations nearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator