A Combination of Pazopanib and Carboplatin in Advanced Solid Malignancies
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Combination of Pazopanib and Carboplatin in Advanced Solid Malignancies|
- Maximum tolerated dose of Pazopanib when used in combination with Carboplatin [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Patients will receive 200mg of Pazopanib, with later subjects receiving higher dosages up to 800mg of Pazopanib. If a given dose level is not well tolerated when given on all days (1-21) of each cycle, the study will no longer use that dosage. Later subjects may take Pazopanib from days 3-19 of the three week cycle to see if that dosing schedule is better tolerated.
If patients experience side effects from Pazopanib or tests indicate some undesirable effects, then the dose level of Pazopanib that they are receiving may need to be adjusted, with increased monitoring.
|Study Start Date:||August 2012|
|Study Completion Date:||July 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: Carboplatin AUC5 + escalating pazopanib
Carboplatin AUC5 IV Day 1 Pazopanib in escalating dosages, 200 mg to 800 mg starting on days 2 or 3 and ending on days 19 or 21
Carboplatin will be administered intravenously over approximately 30 minutes on day 1 of each cycle. The dosage used will be 5 AUC for the first 5 cycles, and will be increased to 6 AUC for the sixth cycle.
Other Names:Drug: Pazopanib
Pazopanib will be administered orally at 200 to 800 mg/kg2. It will be given either on days 1 through 21 of each 3-week cycle, or if needed, it will be given on days 3 through 19.
Other Name: Votrient
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542047
|United States, New Mexico|
|University of New Mexico Cancer Center|
|Albuquerque, New Mexico, United States, 87131-0001|
|Principal Investigator:||Montasur Shaheen, MD||New Mexico Cancer Care Alliance/UNMCC|