Study of GemOx and Vandetanib in Advanced Solid Malignancy
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|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|
|Actual Primary Completion Date :||November 2010|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|