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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00630409
First Posted: March 7, 2008
Last Update Posted: March 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Leonard Appleman, University of Pittsburgh
Results First Submitted: January 14, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Metastatic Renal Cell Carcinoma
Interventions: Drug: Gemcitabine
Drug: Doxil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)

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.

Gemcitabine: 800 mg IV day 1 and 8

Doxil: 24 mg/m2 every 21 days IV


Participant Flow:   Overall Study
    Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)
STARTED   5 
COMPLETED   4 
NOT COMPLETED   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)

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.

Gemcitabine: 800 mg IV day 1 and 8

Doxil: 24 mg/m2 every 21 days IV


Baseline Measures
   Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV) 
Overall Participants Analyzed 
[Units: Participants]
 5 
Age 
[Units: Years]
Median (Full Range)
 59 
 (47 to 73) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      5 100.0% 


  Outcome Measures
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1.  Primary:   Response Rate   [ Time Frame: Up to 18 weeks for individual; Up to 40 months for cohort ]

2.  Secondary:   Time to Progression   [ Time Frame: Up to 40 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Leonard Appleman, MD, PhD
Organization: University of Pittsburgh
phone: 412-648-6538
e-mail: applemanlj@upmc.edu



Responsible Party: Leonard Appleman, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00630409     History of Changes
Other Study ID Numbers: 04-033
First Submitted: February 28, 2008
First Posted: March 7, 2008
Results First Submitted: January 14, 2016
Results First Posted: March 10, 2017
Last Update Posted: March 10, 2017