Phase II Clinical Trial of Gemcitabine and Doxil® for Metastatic Renal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT00630409|
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : March 10, 2017
Last Update Posted : March 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Renal Cell Carcinoma||Drug: Gemcitabine Drug: Doxil||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Clinical Trial of Gemcitabine and Doxil® for Metastatic Renal Cell Carcinoma|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.
800 mg IV day 1 and 8
Other Name: GemzarDrug: Doxil
24 mg/m2 every 21 days IV
- Response Rate [ Time Frame: Up to 18 weeks for individual; Up to 40 months for cohort ]Number of participants that experienced response/total number of participants per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan. Response was defined as Complete Response (CR), the disappearance of all target lesions; Partial Response (PR), a 30% or greater decrease in the sum of the longest diameter of target lesions.
- Time to Progression [ Time Frame: Up to 40 months ]Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
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): NCT00630409
|United States, Pennsylvania|
|Hillman Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Leonard J Appleman, MD, PhD||University of Pittsburgh|