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PS-341 Alone and PS-341 Plus EPOCH Chemotherapy to Treat Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyndham Wilson, National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00054665
First received: February 5, 2003
Last updated: August 10, 2012
Last verified: August 2012
Results First Received: June 25, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: B-Cell Lymphoma
Interventions: Drug: PS-341
Drug: Etoposide
Drug: Doxorubicin
Drug: Vincristine
Drug: Cyclophosphamide
Drug: Prednisone
Drug: Filgrastim

  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
1 patient was deemed ineligible and did not receive any treatment. In addition, per the protocol, patients who require an immediate treatment response for medical reasons will only receive part B of the protocol. This decision will be made by the principal investigator in consultation with the associate investigators (e.g. participants can skip A)

Reporting Groups
  Description
Part A: PS-341 Alone 1.3 mg/m^2 intravenous bolus injection over 3-5 seconds every 3 weeks.Per the protocol, patients who require an immediate treatment response for medical reasons will only receive part B of the protocol. This decision will be made by the principal investigator in consultation with the associate investigators.
Part B: PS-341 & EPOCH PS-341 1.3 mg/m^2 intravenous bolus injection over 3-5 seconds every 3 weeks. EPOCH (etoposide 50 mg/m^2 day continuous intravenous infusion days 1-4, doxorubicin 10 mg/m^2 day continuous intravenous infusion days 1-4, vincristine 0.4 mg/m^2/day continuous intravenous infusion days 1-4, cyclophosphamide 750 mg/m^2 intravenous bolus day 5, prednisone 60 mg/m^2 by mouth days 1-5, and filgrastim 300 micrograms subcutaneously day 6 to absolute neutrophil count (ANC) recovery >/= 5000/mm^3.Per the protocol, patients who require an immediate treatment response for medical reasons will only receive part B of the protocol. This decision will be made by the principal investigator in consultation with the associate investigators.

Participant Flow for 2 periods

Period 1:   Part A
    Part A: PS-341 Alone     Part B: PS-341 & EPOCH  
STARTED     23 [1]   0  
COMPLETED     23     0  
NOT COMPLETED     0     0  
[1] 5 participants only received Part A and 18 participants received Part B after Part A.

Period 2:   Part B
    Part A: PS-341 Alone     Part B: PS-341 & EPOCH  
STARTED     0     44 [1]
COMPLETED     0     44  
NOT COMPLETED     0     0  
[1] 26 participants received only Part B



  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
Arm A & B: PS-341 and PS-341 & EPOCH

Part A: PS-341 Alone

1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks Part B: PS-341 & EPOCH

PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.

EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycles every 21 days


Baseline Measures
    Arm A & B: PS-341 and PS-341 & EPOCH  
Number of Participants  
[units: participants]
  50  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     36  
>=65 years     14  
Age  
[units: years]
Mean ± Standard Deviation
  53.04  ± 16.46  
Gender  
[units: participants]
 
Female     14  
Male     36  
Ethnicity (NIH/OMB)  
[units: Participants]
 
Hispanic or Latino     1  
Not Hispanic or Latino     48  
Unknown or Not Reported     1  
Race (NIH/OMB)  
[units: Participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     45  
More than one race     0  
Unknown or Not Reported     1  
Region of Enrollment  
[units: participants]
 
United States     50  



  Outcome Measures
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1.  Primary:   Clinical Response Rate   [ Time Frame: 18 weeks ]

2.  Primary:   Number of Participants With Adverse Events   [ Time Frame: 43 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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Wyndham Wilson, M.D.
Organization: National Cancer Institute, National Institues of Health
phone: 301-435-2415
e-mail: wilsonw@mail.nih.gov


Publications:

Responsible Party: Wyndham Wilson, National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00054665     History of Changes
Obsolete Identifiers: NCT00057902
Other Study ID Numbers: 030096, 03-C-0096
Study First Received: February 5, 2003
Results First Received: June 25, 2012
Last Updated: August 10, 2012
Health Authority: United States: Federal Government