Clinical trial NCT00923247
Conditions: Medullary Thyroid Carcinoma
Keywords: Vandetanib Bortezomib Medullary Thyroid Proteasome Inhibitor Cancer Solid Tumor Thyroid Cancer Medullary Thyroid Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2009-02-19; Completion date: 2016-12-09
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Background:

* The combination of anti-cancer drugs vandetanib (given orally) and bortezomib (given intravenously) has not been used in humans. However, both drugs have been studied separately. Bortezomib has been approved by the U.S. Food and Drug Administration (FDA) for treating multiple myeloma and mantle cell lymphoma, while vandetanib is still under investigation pending FDA approval.
* Both bortezomib and vandetanib are under investigation for use in treating certain kinds of cancer. Researchers hope that the combination of these two drugs will be more effective than either of them alone.

Objectives:

* To determine if the combination of vandetanib and bortezomib will decrease the amount of the cancer and, if it does, to determine how long the response will last.
* To determine any side effects that may occur with this combination of treatments.
* To determine what doses of each drug are well tolerated and safe when given together.
* To study genetic mutations in tumors to better understand how tumors grow and how these drugs interact with the tumor.

Eligibility:

* Patients 18 years of age and older with solid tumors that cannot be surgically removed and have either recurred or shown further growth. The tumor(s) must be able to be evaluated by X-ray, MRI (magnetic resonance imaging), and CT (computerized tomography) scanning.
* Patients who have been diagnosed with medullary thyroid cancer will participate in Phase II of the study.

Design:

* Tumor samples may be taken at the start of the study for research purposes.
* Phase I: Patient groups will be treated on an outpatient basis with vandetanib and bortezomib, given at increasing doses over four different levels to determine the maximum tolerated dose calculated by height and weight:
* Doses will be given on Days 1, 4, 8, and 11 for each 28-day cycle.
* Two additional levels (Level 1A and Level 1B) may be included in the study, depending on side effects at various levels.
* Phase II: Patients with medullary thyroid cancer will be divided into two groups, with two patients in Group A for every one patient in Group B. No placebo will be involved in this study.
* Group A: Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study.
* Group B: Patients will be treated with bortezomib alone.
* A second tumor sample may be taken. In patients with thyroid cancer, the second biopsy will be done at the 6-week evaluation (approximately 42 days after beginning). In patients with cancer other than thyroid cancer, the second biopsy will be obtained on Day 4 of either the first or second cycle, after the bortezomib infusion.
* The effects of the drugs will be studied through blood samples and CT scans taken during and after various drug cycles.

Detailed description:
Background:

* Vandetanib (CAPRELSA; ZD6474) potently inhibits vascular endothelial growth factor receptor-2 (VEGFR-2), and shows additional inhibitory activity at sub-micromolar concentrations against the Rearranged during Transfection (RET) receptor, Flt-4 and EGF receptor tyrosine kinases.
* Clinical trials have shown that vandetanib is active against medullary thyroid carcinomas (MTCs), but the activity is characterized by partial responses of variable duration, underscoring the need to develop active combinatorial regimens.
* Bortezomib (PS-341, Velcade ), a proteasome inhibitor, has been reported to have several putative mechanisms of action and it is likely that its toxicity is mediated by affecting more than one pathway or target. Bortezomib is reported to inhibit the nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kappaB) pathway and regulate NF-kappaB-dependent expression of several other inhibitors of apoptosis.
* In vitro studies have shown bortezomib to be active against a broad range of thyroid cancer cell lines. Given this activity of bortezomib and the role of the proteasome in regulating diverse cellular pathways, this study proposes to combine bortezomib with vandetanib to treat patients with advanced solid tumors with a focus on patients with MTC.

Objectives:

* To assess the activity of vandetanib plus bortezomib in adults with MTC, using Response Evaluation Criteria in Solid Tumors (RECIST) and tumor biomarkers including carcinoembryonic antigen (CEA) and calcitonin as endpoints.
* To assess the safety and tolerance of vandetanib plus bortezomib in dose-seeking cohorts.
* To compare the combination bortezomib plus vandetanib versus vandetanib alone in adults with MTC by assessing the response rate and progression-free survival
* In exploratory analyses: (a) examine the correlation between genotype and response to therapy in patients with MTC, (b) examine the extent, if any, of rearranged during transfection (RET) inhibition in patients with MTC following the administration of vandetanib; and (c) examine the effect, if any, of bortezomib on microtubules.

Eligibility:

* Adults age 18 and older with unresectable, recurrent or metastatic solid tumors, including MTC.
* Disease must be evaluable by RECIST.

Design:

* Phase I dose-escalation study followed by randomized phase II trial.
* Maximum total number for planned enrollment: 117 - Dose-seeking cohorts of three to 6 patients until maximum tolerated dose (MTD)/dose limiting toxicity (DLT) reached (up to 24 patients) followed by a randomized phase II trial comparing the activity of the combination of bortezomib plus vandetanib with vandetanib alone (2:1 randomization 62 plus 31 equals 93 patients).
* The MTD and DLT will be determined based on toxicities during the first eight weeks of combined therapy.
* Cycle length will be four weeks. Response will be determined by RECIST every 12 weeks.

Arms: arm 1: Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dose arm 2: Patients will be treated with vandetanib alone. arm 3: Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose (MTD) of the Phase I study
Interventions: intervention 1: Bortezomib intervention 2: Vandetanib
Intervention descriptions: intervention 1: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 \& 11 every 28 days in adults intervention 2: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 \& 11 every 28 days in adults

Protocol documents:
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