Vandetanib and Everolimus in Treating Patients With Advanced or Metastatic Cancer

  • STATUS
    Recruiting
  • End date
    May 31, 2026
  • participants needed
    174
  • sponsor
    M.D. Anderson Cancer Center
Updated on 15 July 2022
cancer
absolute neutrophil count
metastasis
neutrophil count
palliative radiation therapy

Summary

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.

Description

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) or highest dose level, and the dose-limiting toxicity (DLT) of vandetanib (a multi-kinase inhibitor of epidermal growth factor receptor [EGFR], vascular endothelial growth factor receptor [VEGFR] and ret proto-oncogene [RET] inhibitor) when used in combination with everolimus (a mammalian target of rapamycin [mTOR] inhibitor) in advanced cancer.

II. Preliminary descriptive assessment of the anti-tumor efficacy of the combination.

III. Preliminary optional assessment of the pharmacokinetic, pharmacodynamic markers of target inhibition and correlates of response.

OUTLINE: This is a dose-escalation study.

Patients receive vandetanib orally (PO) once daily (QD) and everolimus PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment patients are followed up between 14-28 days at the discretion of the treating physician.

Details
Condition Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm, Recurrent Malignant Neoplasm, Refractory Malignant Neoplasm
Treatment laboratory biomarker analysis, Everolimus, vandetanib, pharmacological study
Clinical Study IdentifierNCT01582191
SponsorM.D. Anderson Cancer Center
Last Modified on15 July 2022

Eligibility

Yes No Not Sure

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
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