Study of GemOx and Vandetanib in Advanced Solid Malignancy
|ClinicalTrials.gov Identifier: NCT00660725|
Recruitment Status : Completed
First Posted : April 17, 2008
Last Update Posted : January 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Advanced Incurable Solid Malignancy||Drug: Vandetanib Drug: Gemcitabine Drug: Oxaliplatin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Phase I Study of Gemcitabine/Oxaliplatin (GEMOX) and Vandetanib (ZACTIMA; ZD6474) Combination in Patients With Advanced Solid Malignancy (IRUSZACT0070) (UPCI 07-025)|
|Study Start Date :||February 2009|
|Primary Completion Date :||November 2010|
|Study Completion Date :||December 2010|
All subjects receive the same combination study drug and follow the same study schedule. As a phase 1 study, only the doses will vary between subjects.
Vandetanib is a pill that will be self-administered orally on Days 1-14 of each 14-day cycle. The dose of vandetanib each subject will receive will be determined by a dose escalation schedule (either 200 mg or 300 mg per day), which will be followed to determine the MTD of the study drug combination (vandetanib + GemOx). In the absence of disease progression, unacceptable toxicities, or other complications, the vandetanib and GemOx combination may continue per protocol for a maximum of 6 cycles, or 12 weeks. In subjects who show response or stable disease, vandetanib may be continued as a single agent beyond the 6 cycle maximum, at the investigator's discretion.
Other Names:Drug: Gemcitabine
30-minute IV infusion of 1000 mg/m^2 gemcitabine on Day 1 of each 14-day cycle.
Other Name: Gemzar®Drug: Oxaliplatin
Immediately following gemcitabine IV: 2-hour IV infusion of 85 mg/m^2 oxaliplatin on Day 1 of each 14-day cycle.
Other Name: Eloxatin®
- To establish the Maximum Tolerated Dose (MTD) and toxicities of vandetanib (Zactima; ZD6474) in combination with fixed dose of GEMOX (gemcitabine/oxaliplatin) and to establish the recommended phase II dose of the GEMOX and vandetanib regimen [ Time Frame: The MTD (and recommended phase II dose) is defined as the highest dose at which <2 of 6 patients experience DLT. The observation period for DLT is the first cycle of therapy. ]
- To document clinical responses and to identify time to progression (TTP) of each patient compared to TTP on prior therapy [ Time Frame: Radiologic imaging is done every 6-7 weeks for disease assessment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660725
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute / Hillman Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Leonard J. Appleman, M.D., Ph.D.||University of Pittsburgh|