A Phase 1 interventional study of Weekly Abraxane and Daily Vandetanib and Abraxane every three weeks and daily vandetanib in Solid Tumors, sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-19.
Sponsored by University of Southern California · Phase 1, Interventional, and Treatment
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.
University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
ANC > 1500/mm3 Platelet count > 100,000 cells/mm3 Hemoglobin > 9.0g/dL Serum creatinine \< 1.5 mg/dl or creatinine clearance > 50 mL/minute Hepatic function: Patients must have adequate liver functions: AST or ALT \< 2.5 X upper limit of normal (ULN), alkaline phosphatase \< 2.5 X upper limit of normal. In patients with bone metastasis and no evidence of liver metastasis and bilirubin \< upper limit of normal an alkaline phosphatase \< 5 ULN will be allowed.
In patients with known liver involvement: AST or ALT and alkaline phosphatase \< 5 ULN, Serum Bilirubin \< 1.5 mg/dL
Exclusion Criteria:
Laboratory results:
Drug: Weekly Abraxane and Daily Vandetanib
Drug: Abraxane every three weeks and daily vandetanib
Abraxane once a week for three weeks, followed by one week with no Abraxane. Vandetanib once a day every day for 28 days. This four week period is called a cycle.
Abraxane on day one of study therapy, followed by 20 days of no Abraxane. Vandetanib once a day every day for 21 days. This three week period is called a cycle.
Dose Limiting Toxicity
Time frame: First Cycle of Study Therapy
RECIST Response
Time frame: Until Patient goes off study
Toxicity
Time frame: Until Patient Goes off study
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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