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Doxorubicin (Doxil) Combined With Rituxan, Cyclophosphamide, Vincristine and Prednisone in Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas

This study has been completed.
Sponsor:
Collaborator:
Ortho Biotech, Inc.
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT00184002
First received: September 12, 2005
Last updated: July 13, 2017
Last verified: July 2017
Results First Received: July 13, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non-Hodgkin's Lymphoma
Intervention: Drug: Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone

  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
The study began recruiting in January 2003 and ended in December 2007. All subjects were seen and treated either at USC Norris Comprehensive Cancer Center or at LAC+USC Medical Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were no pre-assignment criteria. All subjects were given the same treatment.

Reporting Groups
  Description
DR-COP

On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5.

On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5

  • 1 cycle = 21 days.
  • Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.

Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min.

Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min.

Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum).

Prednisone 100 mg po days 1-5.

Cycle 2 until study completion

Doxil 40 mg/m2 iv day 1

Rituxan 375 mg/m2 iv day 1

Cyclophosphamide 750 mg/m2 iv day 1


Participant Flow:   Overall Study
    DR-COP
STARTED   68 
COMPLETED   51 
NOT COMPLETED   17 
Adverse Event                9 
Death                3 
Physician Decision                1 
Withdrawal by Subject                4 



  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
DR-COP

On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5.

On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5

  • 1 cycle = 21 days.
  • Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.

Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min.

Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min.

Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum).

Prednisone 100 mg po days 1-5.

Cycle 2 until study completion

Doxil 40 mg/m2 iv day 1

Rituxan 375 mg/m2 iv day 1

Cyclophosphamide 750 mg/m2 iv day 1


Baseline Measures
   DR-COP 
Overall Participants Analyzed 
[Units: Participants]
 68 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      60  88.2% 
>=65 years      8  11.8% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      39  57.4% 
Male      29  42.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      48  70.6% 
Not Hispanic or Latino      20  29.4% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      12  17.6% 
Native Hawaiian or Other Pacific Islander      1   1.5% 
Black or African American      0   0.0% 
White      7  10.3% 
More than one race      0   0.0% 
Unknown or Not Reported      48  70.6% 
Region of Enrollment 
[Units: Participants]
 
United States   68 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Patients With Complete Response to the Combination Chemotherapy   [ Time Frame: At completion of cycle 4, 6, and 8 ]

2.  Secondary:   Number of Patients With Serious Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: At end of every cycle ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  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: Victoria Soto - Project Specialist
Organization: USC Norris Comprehensive Cancer Center
phone: (323) 865-0454
e-mail: Victoria.Soto@med.usc.edu



Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00184002     History of Changes
Other Study ID Numbers: 13NHL-02-3
Study First Received: September 12, 2005
Results First Received: July 13, 2017
Last Updated: July 13, 2017