Solid Tumors Clinical Trial
Official title:
Phase I Trial of Abraxane Administered on a Weekly and Three Weekly Schedule in Combination With Vandetanib
This study uses the drugs Abraxane (also called ABI-007) and Vandetanib (also called Zactima
and ZD6474). Abraxane has been approved by the Food and Drug Administration (FDA), for the
treatment of breast cancer. Vandetanib is an experimental drug and has not been approved by
the FDA for the treatment of any condition. Vandetanib has shrunk some non-small cell lung
cancer, prostate cancer and thyroid cancer in some studies in humans. This combination of
drugs is not approved for the treatment of any condition by the FDA.
This study is being done in two phases. The first phase of the trial has two main
objectives: 1) To find the highest daily dose of vandetanib that can be given safely with
once weekly Abraxane and 2) To find the highest daily dose of vandetanib that can be given
safely with Abraxane given every three weeks. Participants will be randomly assigned (like
flipping a coin) to receive Abraxane weekly (Arm A) or once every three weeks (Arm B). The
dose of Abraxane given will remain the same for the whole study - 100 mg/m2 when given
weekly and 260 mg/m2 when given every three weeks. Participants will be entered onto each
arm of the study in groups of three, and higher doses of vandetanib will be given each group
of participants. The increase of vandetanib will stop once more than one participant has
serious side effects. The highest dose of vandetanib that can be given with Abraxane
(without serious side effects) in each Arm will be called the pilot dose.
In the second phase of the study twenty participants will be randomly assigned to Arm A or
Arm B and receive the pilot dose of vandetanib that was reached in the first phase of the
study. The purpose of the second phase of the study is to see how many tumors shrink when
participants receive the pilot dose of the drug combination on each Arm, as well as to
gather more information about the side effects.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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