Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-27 @ 11:32 PM
Study NCT ID:
NCT01622660
Status:
TERMINATED
Last Update Posted:
2017-08-22
First Post:
2012-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gemcitabine and Pazopanib in Chemotherapy Naïve Patients With Advanced/Metastatic Urothelial Carcinoma Ineligible for Cisplatin-based Chemotherapy
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Study Overview
Official Title:
Phase II Study of Gemcitabine and Pazopanib in Chemotherapy Naïve Patients With Advanced/Metastatic Urothelial Carcinoma Ineligible for Cisplatin-based Chemotherapy
Status:
TERMINATED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Safety reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gemcitabine and Cisplatin are standard chemotherapy drugs used to treat advanced urothelial cancer. There is no standard chemotherapy for patients who cannot receive Cisplatin. However, most patients are treated with the chemotherapy drugs Gemcitabine and Carboplatin.
In this study, the researchers hope to learn what effects, good and/or bad, the combination of Gemcitabine and Pazopanib has on urothelial cancer. Gemcitabine is given intravenously (through the veins) and works by killing rapidly dividing cells in the body, including cancer cells. Pazopanib is an oral chemotherapy and works by decreasing the blood supply to tumors which limits the tumor's source of oxygen and nutrients.
The combination of Gemcitabine and Pazopanib is being tested in research studies such as this one. As of August 2011, more than 18 patients with various types of cancer have received treatment with Gemcitabine and Pazopanib. The main goal of this clinical research study is to learn if the study drugs Gemcitabine and Pazopanib can shrink or slow the growth of urothelial cancer. The safety of this drug will also be studied. The physical state, changes in the size of the tumor, and laboratory findings will help us decide if the combination of Gemcitabine and Pazopanib is safe and effective.
In this study, the researchers hope to learn what effects, good and/or bad, the combination of Gemcitabine and Pazopanib has on urothelial cancer. Gemcitabine is given intravenously (through the veins) and works by killing rapidly dividing cells in the body, including cancer cells. Pazopanib is an oral chemotherapy and works by decreasing the blood supply to tumors which limits the tumor's source of oxygen and nutrients.
The combination of Gemcitabine and Pazopanib is being tested in research studies such as this one. As of August 2011, more than 18 patients with various types of cancer have received treatment with Gemcitabine and Pazopanib. The main goal of this clinical research study is to learn if the study drugs Gemcitabine and Pazopanib can shrink or slow the growth of urothelial cancer. The safety of this drug will also be studied. The physical state, changes in the size of the tumor, and laboratory findings will help us decide if the combination of Gemcitabine and Pazopanib is safe and effective.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: