NCT00630409

Phase II Clinical Trial of Gemcitabine and Doxil® for Metastatic Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the hypothesis that the combination of gemcitabine and doxil will have clinical activity in patients with metastatic renal cell carcinoma.

Detailed description

Patients with metastatic renal cell carcinoma who have received prior therapy with sorafenib, sunitinib or temsirolimus and have progressive disease may participate in this study if all eligibility criteria are met. Doxil will be administered on day 1 and gemcitabine on day 1 and 8 of a 21 day cycle. Tumor responses will be evaluated by RECIST. Up to six cycles of study treatment may be administered. Cardiac ejection fraction will be monitored.

Conditions

• Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine	800 mg IV day 1 and 8
DRUG	Doxil	24 mg/m2 every 21 days IV

Timeline

• Start date: 2004-09-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2008-03-07
• Last updated: 2017-03-10
• Results posted: 2017-03-10

Locations

1 site across 1 country: United States