Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 99 of 2030 for:    doxil

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

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.
 
ClinicalTrials.gov Identifier: NCT00184002
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : August 10, 2017
Last Update Posted : August 10, 2017
Sponsor:
Collaborator:
Ortho Biotech, Inc.
Information provided by (Responsible Party):
University of Southern California

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
Enrollment 68
Recruitment Details 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 There were no pre-assignment criteria. All subjects were given the same treatment.
Arm/Group Title DR-COP
Hide Arm/Group Description

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

Period Title: Overall Study
Started 68
Completed 51
Not Completed 17
Reason Not Completed
Adverse Event             9
Death             3
Physician Decision             1
Withdrawal by Subject             4
Arm/Group Title DR-COP
Hide Arm/Group Description

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

Overall Number of Baseline Participants 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
<=18 years
0
   0.0%
Between 18 and 65 years
60
  88.2%
>=65 years
8
  11.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
Female
39
  57.4%
Male
29
  42.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
Hispanic or Latino
48
  70.6%
Not Hispanic or Latino
20
  29.4%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 68 participants
68
1.Primary Outcome
Title Percentage of Patients With Complete Response to the Combination Chemotherapy
Hide Description

Initial disease response tests will be performed after cycle 4 on all patients. Subsequent assessments after cycles 6 and/or 8 will depend on response. If after 4 cycles of therapy complete response or partial response has been documented, therapy will continue. If stable or progressive disease has been documented, the patient will be withdrawn from the study.

Response to the study treatment will be determined according to the criteria proposed in the “Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas” by Cheson et al (23).

Time Frame At completion of cycle 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DR-COP
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: Percentage of participants
Complete Response 75.0
Partial Response 23.0
2.Secondary Outcome
Title Number of Patients With Serious Adverse Events as a Measure of Safety and Tolerability
Hide Description Summary of grade 3 or higher toxicities (per Common Toxicity Criteria version 2.0) which generally is described as severe adverse reaction or symptom.
Time Frame At end of every cycle
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DR-COP
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 68
Measure Type: Count of Participants
Unit of Measure: Participants
35
  51.5%
Time Frame Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DR-COP
Hide Arm/Group Description

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

All-Cause Mortality
DR-COP
Affected / at Risk (%)
Total   3/68 (4.41%)    
Show Serious Adverse Events Hide Serious Adverse Events
DR-COP
Affected / at Risk (%) # Events
Total   35/68 (51.47%)    
Blood and lymphatic system disorders   
Neutrophils/granulocytes (ANC/AGC)  1  35/68 (51.47%)  42
Hemoglobin  1  11/68 (16.18%)  13
Leukocytes (total WBC)  1  1/68 (1.47%)  2
Platelets  1  5/68 (7.35%)  9
Cardiac disorders   
Cardiac left ventricular function  1  1/68 (1.47%)  1
Hypertension  1  2/68 (2.94%)  2
Hypotension  1  2/68 (2.94%)  2
Gastrointestinal disorders   
Abdominal pain or cramping  1  2/68 (2.94%)  4
Diarrhea patients without colostomy  1  1/68 (1.47%)  1
Ileus (or neuroconstipation)  1  2/68 (2.94%)  2
Melena/GI bleeding  1  1/68 (1.47%)  1
Nausea  1  2/68 (2.94%)  2
Stomatitis/pharingitis (oral/pharyngeal mucositis)  1  2/68 (2.94%)  2
Vomiting  1  2/68 (2.94%)  2
General disorders   
Fatigue (lethargy, malaise, asthenia)  1  1/68 (1.47%)  1
Weight loss  1  1/68 (1.47%)  1
Hepatobiliary disorders   
Bilirubin  1  1/68 (1.47%)  1
SGOT (AST) (serum glutamic oxaloacetic transaminase)  1  3/68 (4.41%)  3
SGPT (ALT) (serum glutamic pyruvic transaminase)  1  3/68 (4.41%)  3
Infections and infestations   
Febrile neutropenia  1 [1]  8/68 (11.76%)  8
Infection  1 [2]  8/68 (11.76%)  8
Infection without neutropenia  1  6/68 (8.82%)  6
Investigations   
Cardiac troponin I (cTnl)  1  1/68 (1.47%)  1
Metabolism and nutrition disorders   
Anorexia  1  1/68 (1.47%)  1
Dehydration  1  1/68 (1.47%)  1
Hyperglycemia  1  2/68 (2.94%)  5
Hypocalcemia  1  1/68 (1.47%)  1
Hypokalemia  1  3/68 (4.41%)  5
Hyponatremia  1  1/68 (1.47%)  1
Hypophosphatemia  1  1/68 (1.47%)  1
Tumor lysis syndrome  1  1/68 (1.47%)  1
Musculoskeletal and connective tissue disorders   
Myalgia (muscle pain)  1  1/68 (1.47%)  1
Nervous system disorders   
Neuropathy-sensory  1  2/68 (2.94%)  2
Renal and urinary disorders   
Incontinence  1  1/68 (1.47%)  1
Ureteral obstruction  1  1/68 (1.47%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  6/68 (8.82%)  6
Hypoxia  1  2/68 (2.94%)  2
Pleural effusion (non-malignant)  1  1/68 (1.47%)  1
Pneumonitis/pulmonary infiltrates  1  1/68 (1.47%)  2
Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)  1  1/68 (1.47%)  1
Skin and subcutaneous tissue disorders   
Hand-foot skin reaction  1  10/68 (14.71%)  10
1
Term from vocabulary, CTCAE (2.0)
Indicates events were collected by systematic assessment
[1]
Fever of unknown origin without clinically or microbiologically documented infection (ANC <1.0 x 10e9/L, fever >= 38.5 degrees C)
[2]
Documented clinically or microbiologically with grade 3 or 4 neutropenia (ANC <1.0 x 10e9/L)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DR-COP
Affected / at Risk (%) # Events
Total   27/68 (39.71%)    
Blood and lymphatic system disorders   
Hemoglobin  1  23/68 (33.82%)  42
Leukocytes (total WBC)  1  1/68 (1.47%)  2
Neutrophils/granulocytes (ANC/AGC)  1  19/68 (27.94%)  34
Platelets  1  6/68 (8.82%)  14
Cardiac disorders   
Cardiac left ventricular function  1  1/68 (1.47%)  1
Hypertension  1  5/68 (7.35%)  5
Hypotension  1  3/68 (4.41%)  3
Sinus bradycardia  1  3/68 (4.41%)  3
Sinus tachycardia  1  7/68 (10.29%)  10
Thrombosis/embolism  1  1/68 (1.47%)  1
Endocrine disorders   
Hot flashes/flushes  1  2/68 (2.94%)  2
Eye disorders   
Conjunctivitis  1  3/68 (4.41%)  3
Dry eye  1  1/68 (1.47%)  1
Vision-blurred vision  1  1/68 (1.47%)  1
Gastrointestinal disorders   
Abdominal pain or cramping  1  12/68 (17.65%)  14
Ascites (non-malignant)  1  1/68 (1.47%)  1
Constipation  1  19/68 (27.94%)  25
Diarrhea patients without colostomy  1  12/68 (17.65%)  16
Dyspepsia/heartburn  1  7/68 (10.29%)  7
Dysphagia, esophagitis, odynophagia (painful swallowing)  1  5/68 (7.35%)  5
Flatulence  1  1/68 (1.47%)  1
Ileus (or neuroconstipation)  1  1/68 (1.47%)  1
Melena/GI bleeding  1  1/68 (1.47%)  1
Mouth dryness  1  1/68 (1.47%)  1
Nausea  1  22/68 (32.35%)  37
Sense of smell  1  2/68 (2.94%)  2
Stomatitis/pharyngitis (oral/pharyngeal mucositis)  1  17/68 (25.00%)  24
Taste disturbance (dysgeusia)  1  14/68 (20.59%)  17
Vomiting  1  14/68 (20.59%)  22
General disorders   
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  1  1/68 (1.47%)  1
Chest pain (non-cardiac and non-pleuritic)  1  1/68 (1.47%)  1
Edema  1  11/68 (16.18%)  16
Fatigue (lethargy, malaise, asthenia)  1  22/68 (32.35%)  32
Fever  1 [1]  11/68 (16.18%)  12
Pain due to radiation  1  1/68 (1.47%)  1
Pain  1  27/68 (39.71%)  63
Rigors, chills  1  3/68 (4.41%)  3
Sweating (eiaphoresis)  1  2/68 (2.94%)  2
Weight loss  1  2/68 (2.94%)  2
Hepatobiliary disorders   
Alkaline phosphatase  1  1/68 (1.47%)  1
Bilirubin  1  1/68 (1.47%)  1
Hypoalbuminemia  1  1/68 (1.47%)  1
SGOT (AST) (serum glutamic oxaloacetic transaminase)  1  5/68 (7.35%)  7
SGPT (ALT) (serum glutamic pyruvic transaminase)  1  5/68 (7.35%)  8
Infections and infestations   
Infection without neutropenia  1  9/68 (13.24%)  15
Wound-infectious  1  1/68 (1.47%)  1
Injury, poisoning and procedural complications   
Hemorrhage/bleeding  1 [2]  1/68 (1.47%)  1
Skin-Laate RT Morbidity Scoring  1  2/68 (2.94%)  2
Metabolism and nutrition disorders   
Alkalosis (metabolic or respiratory)  1  1/68 (1.47%)  1
Anorexia  1  16/68 (23.53%)  19
Dehydration  1  1/68 (1.47%)  2
Hypercalcemia  1  1/68 (1.47%)  1
Hypercholesterolemia  1  2/68 (2.94%)  2
Hyperglycemia  1  15/68 (22.06%)  27
Hypermagnesemia  1  1/68 (1.47%)  1
Hypocalcemia  1  1/68 (1.47%)  1
Hypokalemia  1  6/68 (8.82%)  7
Hypomagnesemia  1  2/68 (2.94%)  2
Hypophosphatemia  1  1/68 (1.47%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia (joint pain)  1  5/68 (7.35%)  5
Bone pain  1  5/68 (7.35%)  11
Muscle weakness (not due to neuropathy)  1  4/68 (5.88%)  5
Myalgia (muscle pain)  1  2/68 (2.94%)  3
Nervous system disorders   
Dizziness/lightheadedness  1  4/68 (5.88%)  4
Headache  1  14/68 (20.59%)  17
Neuropathy-motor  1  1/68 (1.47%)  1
Neuropathy-sensory  1  1/68 (1.47%)  1
Psychiatric disorders   
Insomnia  1  15/68 (22.06%)  16
Mood alteration-anxiety, agitation  1  2/68 (2.94%)  2
Mood alteration-depression  1  3/68 (4.41%)  3
Renal and urinary disorders   
Creatinine  1  1/68 (1.47%)  1
Dysuria (painful urination)  1  2/68 (2.94%)  2
Incontinence  1  1/68 (1.47%)  1
Urinary frequency/urgency  1  1/68 (1.47%)  1
Urinary retention  1  2/68 (2.94%)  2
Respiratory, thoracic and mediastinal disorders   
Cough  1  8/68 (11.76%)  8
Dyspnea (shortness of breath)  1  9/68 (13.24%)  9
Hemoptysis  1  1/68 (1.47%)  1
Pleural Effusion (non-malignant)  1  1/68 (1.47%)  1
Pneumothorax  1  1/68 (1.47%)  1
Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)  1  1/68 (1.47%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1  24/68 (35.29%)  30
Hand-foot skin reaction  1  18/68 (26.47%)  23
Pigmentation changes (e.g., vitiligo)  1  2/68 (2.94%)  4
Pruritus  1  4/68 (5.88%)  4
Rash/desquamation  1  9/68 (13.24%)  10
1
Term from vocabulary, CTCAE (2.0)
Indicates events were collected by systematic assessment
[1]
In the absence of neutropenia, where neutropenia is defined as AGC <1.0 x 10e9/L
[2]
Without grade 3 or 4 thrombocytopenia
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Victoria Soto - Project Specialist
Organization: USC Norris Comprehensive Cancer Center
Phone: (323) 865-0454
EMail: Victoria.Soto@med.usc.edu
Layout table for additonal information
Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00184002     History of Changes
Other Study ID Numbers: 13NHL-02-3
First Submitted: September 12, 2005
First Posted: September 16, 2005
Results First Submitted: July 13, 2017
Results First Posted: August 10, 2017
Last Update Posted: August 10, 2017