• Return to search results
• Start new search

Investigator(s):
Antonio Tito Fojo, M.D., Ph.D. Principal Investigator Phone: 301-402-1357 tfojo@helix.nih.gov
Referral Contact(s):
Maureen Edgerly, R.N., M.A., C.C.R.C., O.C.N. Research Nurse Phone: 301-435-5604 Fax: 301-402-1608 edgerlym@mail.nih.gov

---

Primary Eligibility:

• Pathologically confirmed recurrent, metastatic, or primary unresectable cancer, including one of the following:
• Solid tumor for which no known curative standard therapy exists (phase I)
• Medullary thyroid cancer (phase II)
• Disease not potentially curable by surgical excision alone
• Measurable disease by RECIST criteria OR measurement of serum markers
• Measurable disease by RECIST criteria required for patients enrolled in the phase II portion of the study
• No untreated brain metastases OR locally treated brain metastases within the past 6 months
• Recovered from prior therapy
• No prior bevacizumab, sunitinib malate, sorafenib tosylate, or any agent thought to have VEGF or VEGFR as a principal target, unless the agent was administered for < 8 weeks AND and was discontinued due to toxicity
• No concurrent medications that may cause QTc prolongation
• No concurrent medications that may induce Torsades de Pointes
• No concurrent medications that are potent inducers of CYP3A4 function
• ECOG performance status 0–1
• ANC ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³
• PT ≤ 4 seconds above upper limit of normal (ULN)
• PTT ≤ 10 seconds above ULN
• Total bilirubin < 1.5 x ULN (unless the patient meets criteria for Gilbert's syndrome)
• ALT, AST and alkaline phosphatase < 2.5 x ULN (5 x ULN if judged by the investigator to be related to liver metastasis)
• Serum creatinine < 1.5 x ULN OR creatinine clearance ≥ 30 mL/min
• Serum calcium < CTCAE upper limit of grade 1
• Serum potassium > lower limit of normal (LLN) but < 5.5 mmol/L
• Serum magnesium > LLN but < 3 mg/dL or 1.23 mmol/L
• Not pregnant or nursing; fertile patients must use effective contraception during and for ≥ 2 months (or five half-lives) after completion of study treatment
• Able to take oral medications
• No medical condition that would preclude study participation
• No second malignancy within the past 2 years, except for squamous cell carcinoma of the skin or in situ cervical cancer

---

Study Outline:

This is a phase I dose-escalation study followed by a randomized phase II study.

Phase I:

• Patients receive oral vandetanib once daily on Days 1–28 and bortezomib IV on Days 1, 4, 8, and 11
• Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity

Phase II:

• Patients are randomized to one of two treatment arms
• Arm I
• Patients receive oral vandetanib once daily on Days 1–28 and bortezomib IV on Days 1, 4, 8 and 11
• Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
• Arm II
• Patients receive vandetanib as in arm I

• Blood samples are collected periodically
• Tumor tissue samples are collected at baseline
• After completion of study treatment, patients are followed every 3–4 months

---

Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 6/19/09
Updated: 6/22/09