Vandetanib and Everolimus in Treating Patients With Advanced or Metastatic Cancer

Overview

The goal of this clinical research study is to find the highest tolerable dose of the combination of vandetanib and everolimus that can be given to patients with advanced cancer.

The effects of the study drugs at different dose levels and the safety of the study drugs will also be studied.

Vandetanib and everolimus are both designed to harm cancer cells, stopping their growth. This may stop or slow the growth or spread of cancer cells.

SparkCures ID 279
Trial Phase Phase 1
Enrollment 118 Patients
Treatments
Trial Sponsors
  • MD Anderson Cancer Center
NCT Identifier

NCT01582191

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months
  • Patients must be at least 3 weeks beyond their previous cytotoxic chemotherapy; patient must be at least 5 half-lives or 3 weeks, whichever is shorter, from their previous targeted or biologic therapy; in addition, patients must be at least 3 weeks beyond the last session of radiation therapy; local palliative radiation therapy that is not delivered to all target lesions is allowed immediately before or during treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status should be less or equal to 3
  • Absolute neutrophil count more or equal to 750/mL
  • Platelets more or equal to 50,000/mL
  • Creatinine less or equal to 3 x upper limit of normal (ULN)
  • Total bilirubin less than or equal to 3.0
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence)

Exclusion Criteria:

  • Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support
  • Pregnant or lactating women
  • History of hypersensitivity to vandetanib, lactose, murine products, or any component of the formulation
  • History of hypersensitivity to sirolimus, temsirolimus, everolimus
  • History of hypersensitivity to any component of the formulation
  • Patients unwilling or unable to sign informed consent document
  • Presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia
  • History (within the last 3 months) or presence of stroke/cerebrovascular accident
  • Congenital long QT syndrome
  • Corrected QT for Fridericia (QTcF) interval greater than 500 ms that is not correctable to less than 500 ms such as with cessation of a causative medication, etc
  • History of myocardial infarction within 6 months with a residual arrhythmia that in the opinion of the investigator, increases the risk of ventricular arrhythmia
  • Presence of a symptomatic bradyarrhythmia or uncompensated heart failure

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Texas

Resources

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