Phase I Abraxane Weekly and Three Weekly Schedule With Vandetanib
|ClinicalTrials.gov Identifier: NCT00667147|
Recruitment Status : Completed
First Posted : April 25, 2008
Last Update Posted : November 19, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: Weekly Abraxane and Daily Vandetanib Drug: Abraxane every three weeks and daily vandetanib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Abraxane Administered on a Weekly and Three Weekly Schedule in Combination With Vandetanib|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||June 2014|
Drug: Weekly Abraxane 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.
Drug: Abraxane every three weeks and daily vandetanib
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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667147
|United States, California|
|University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Anthony El-Khoueiry, M.D.||U.S.C. / Norris Comprehensive Cancer Center|