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Mitoxantrone ± Cetuximab 2nd Line Androgen Independent Prostate Cancer (AIPC)

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: NCT00661492
Recruitment Status : Completed
First Posted : April 18, 2008
Results First Posted : December 9, 2016
Last Update Posted : December 9, 2016
Sponsor:
Collaborators:
ImClone LLC
Oregon Health and Science University
Information provided by (Responsible Party):
US Oncology Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Androgen-independent Prostate Cancer
Interventions Drug: cetuximab
Drug: Mitoxantrone
Enrollment 115
Recruitment Details Between May 2008 and March 2009, 115 eligible patients were enrolled, 75 in the CMP arm and 40 in the MP arm.
Pre-assignment Details 5 patients with Withdrew Consent and 23 patients with Failed Entry.
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description Novantrone+Erbitux Novantrone
Period Title: Overall Study
Started 75 40
Completed 7 11
Not Completed 68 29
Reason Not Completed
Adverse Event             16             13
Disease Progression             44             14
Patient Request             6             1
Investigator Request             1             0
Lost to Follow-up             0             1
Other             1             0
Arm/Group Title Arm 1 Arm 2 Total
Hide Arm/Group Description Novantrone+Erbitux Novantrone Total of all reporting groups
Overall Number of Baseline Participants 75 40 115
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 40 participants 115 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
  22.7%
8
  20.0%
25
  21.7%
>=65 years
58
  77.3%
32
  80.0%
90
  78.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 40 participants 115 participants
71.5  (8.7) 70.7  (8.1) 71.2  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 40 participants 115 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
75
 100.0%
40
 100.0%
115
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants 40 participants 115 participants
Caucasian 65 32 97
Hispanic 4 3 7
Black 5 5 10
Asian 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 75 participants 40 participants 115 participants
75 40 115
1.Primary Outcome
Title Median Time to Progression (TTP)
Hide Description TTP will be measured from the start of treatment date to the date the patient is first recorded as having disease progression (even in patients who discontinue study treatment early due to toxicity or death due to disease progression.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
Novantrone+Erbitux
Novantrone
Overall Number of Participants Analyzed 75 40
Median (Full Range)
Unit of Measure: Months
4.9
(0.5 to 20.5)
6.6
(0.3 to 23.1)
2.Secondary Outcome
Title 2-year Radiographically Evident Progression-free Survival (REPFS).
Hide Description

Radiographic progression:

1) For bone scan, 2 unequivocal new lesions confirmed by a subsequent bone scan with at least 1 more new lesion; 2) Skeletal related event (eg, fracture, need for radiation to bone for pain, spinal cord compression, need for surgery to bone to prevent or treat a pathologic fracture).

Time Frame 24 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received bone scans or had bone progression only (bone pain/pathologic fracture/palliative radiation).
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
Novantrone+Erbitux
Novantrone
Overall Number of Participants Analyzed 50 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability of REPFS at 2-year
0.73
(0.56 to 0.85)
0.80
(0.55 to 0.92)
3.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description ORR = CR + PR Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with solid tumors
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
Novantrone+Erbitux
Novantrone
Overall Number of Participants Analyzed 45 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2.2
(0.1 to 11.8)
3.8
(0.1 to 19.6)
4.Secondary Outcome
Title Median Time to Prostate-specific Antigen (PSA) Progression
Hide Description Defined as the time from initiation of therapy until the first 25% increase from baseline in non-responders or 50% increase from nadir in responders as defined above. A minimum increase in the PSA of 5 ng/mL will be required for progression.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with Prostate-specific antigen (PSA) Information
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
Novantrone+Erbitux
Novantrone
Overall Number of Participants Analyzed 65 34
Median (Full Range)
Unit of Measure: Months
2.7
(0.03 to 24.1)
2.7
(0.03 to 22.3)
5.Secondary Outcome
Title Prostate-specific Antigen (PSA) Response Rate
Hide Description Defined as the fraction of patients with a ≥50% reduction in serum PSA confirmed by a second serum PSA at least 3 weeks later
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population with Prostate-specific antigen (PSA) Information
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
Novantrone+Erbitux
Novantrone
Overall Number of Participants Analyzed 65 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
7.7
(2.5 to 17.0)
17.6
(6.8 to 34.5)
6.Secondary Outcome
Title Prostate-specific Antigen (PSA) Doubling Time
Hide Description PSA doubling time = [log (2)× t] ÷ [log (final PSA) - log (initial PSA)]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population with Prostate-specific antigen (PSA) Information
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
Novantrone+Erbitux
Novantrone
Overall Number of Participants Analyzed 65 34
Median (Full Range)
Unit of Measure: months
2.3
(-61.3 to 62.8)
1.5
(-2544 to 76.4)
7.Secondary Outcome
Title Median Progression-free Survival (PFS)
Hide Description PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
Novantrone+Erbitux
Novantrone
Overall Number of Participants Analyzed 75 40
Median (Full Range)
Unit of Measure: months
4.2
(0.5 to 20.5)
5.5
(0.3 to 23.1)
8.Secondary Outcome
Title Median Overall Survival (OS)
Hide Description OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
Time Frame 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
Novantrone+Erbitux
Novantrone
Overall Number of Participants Analyzed 75 40
Median (Full Range)
Unit of Measure: months
11.9
(0.5 to 24.1)
15.7
(0.9 to 29.4)
Time Frame During the whole treatment period, up to 30 days following last dose
Adverse Event Reporting Description For treated patients only, assessed at each treatment visit
 
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description Novantrone+Erbitux Novantrone
All-Cause Mortality
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 Arm 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/75 (52.00%)      12/39 (30.77%)    
Blood and lymphatic system disorders     
ANEMIA  1  4/75 (5.33%)  4 0/39 (0.00%)  0
EDEMA  1  0/75 (0.00%)  0 1/39 (2.56%)  1
FEBRILE NEUTROPENIA  1  1/75 (1.33%)  1 0/39 (0.00%)  0
GI HEMORRHAGE  1  1/75 (1.33%)  1 0/39 (0.00%)  0
NEUTROPENIA  1  2/75 (2.67%)  2 1/39 (2.56%)  1
NOSEBLEED  1  1/75 (1.33%)  1 0/39 (0.00%)  0
Cardiac disorders     
FIBRILLATION ATRIAL  1  1/75 (1.33%)  1 1/39 (2.56%)  1
FLUTTER ATRIAL  1  1/75 (1.33%)  1 0/39 (0.00%)  0
ISCHEMIA MYOCARDIAL  1  1/75 (1.33%)  1 0/39 (0.00%)  0
MYOCARDIAL INFARCTION  1  1/75 (1.33%)  1 0/39 (0.00%)  0
TACHYCARDIA  1  1/75 (1.33%)  1 0/39 (0.00%)  0
Endocrine disorders     
PROSTATIC DISORDER  1  1/75 (1.33%)  1 0/39 (0.00%)  0
Gastrointestinal disorders     
ANOREXIA  1  1/75 (1.33%)  1 0/39 (0.00%)  0
CONSTIPATION  1  1/75 (1.33%)  1 1/39 (2.56%)  1
DEHYDRATION  1  3/75 (4.00%)  3 0/39 (0.00%)  0
DIARRHEA  1  0/75 (0.00%)  0 1/39 (2.56%)  1
GASTROINTESTINAL BLEEDING  1  1/75 (1.33%)  1 0/39 (0.00%)  0
NAUSEA  1  1/75 (1.33%)  1 0/39 (0.00%)  0
RECTAL BLEEDING  1  1/75 (1.33%)  1 1/39 (2.56%)  1
RECTAL DISORDER  1  1/75 (1.33%)  1 0/39 (0.00%)  0
RECTAL PAIN  1  1/75 (1.33%)  1 0/39 (0.00%)  0
RENAL FAILURE  1  3/75 (4.00%)  3 1/39 (2.56%)  1
VOMITING  1  1/75 (1.33%)  1 0/39 (0.00%)  0
General disorders     
CHEST PAIN  1  1/75 (1.33%)  1 0/39 (0.00%)  0
CHILLS  1  1/75 (1.33%)  1 0/39 (0.00%)  0
MULTIPLE ORGAN FAILURE  1  1/75 (1.33%)  1 0/39 (0.00%)  0
PAIN  1  2/75 (2.67%)  2 0/39 (0.00%)  0
WEAKNESS  1  3/75 (4.00%)  3 2/39 (5.13%)  2
Immune system disorders     
ALLERGIC REACTION  1  1/75 (1.33%)  1 0/39 (0.00%)  0
Infections and infestations     
CELLULITIS  1  1/75 (1.33%)  1 0/39 (0.00%)  0
FEVER  1  1/75 (1.33%)  1 0/39 (0.00%)  0
INFECTION BACTERIAL  1  4/75 (5.33%)  4 0/39 (0.00%)  0
INFECTION BLADDER  1  3/75 (4.00%)  3 0/39 (0.00%)  0
INFECTION VIRAL  1  1/75 (1.33%)  1 0/39 (0.00%)  0
Investigations     
DEATH SUDDEN (NOS)  1  1/75 (1.33%)  1 0/39 (0.00%)  0
DISEASE PROGRESSION  1  4/75 (5.33%)  4 0/39 (0.00%)  0
Metabolism and nutrition disorders     
HYPOKALAEMIA  1  1/75 (1.33%)  1 0/39 (0.00%)  0
Musculoskeletal and connective tissue disorders     
FRACTURE PATHOLOGICAL  1  2/75 (2.67%)  2 0/39 (0.00%)  0
MUSCLE WEAKNESS  1  2/75 (2.67%)  2 0/39 (0.00%)  0
MYALGIA  1  0/75 (0.00%)  0 1/39 (2.56%)  1
PAIN BACK  1  2/75 (2.67%)  2 0/39 (0.00%)  0
PAIN PELVIC  1  1/75 (1.33%)  2 0/39 (0.00%)  0
PAIN SACROILIAC  1  0/75 (0.00%)  0 1/39 (2.56%)  1
SPINAL CORD COMPRESSION  1  1/75 (1.33%)  1 1/39 (2.56%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
BRAIN METASTASES  1  0/75 (0.00%)  0 1/39 (2.56%)  1
Nervous system disorders     
BELL'S PALSY  1  1/75 (1.33%)  1 0/39 (0.00%)  0
CONFUSION  1  1/75 (1.33%)  1 0/39 (0.00%)  0
DIZZINESS  1  1/75 (1.33%)  1 1/39 (2.56%)  1
MENTAL DEFICIENCY  1  1/75 (1.33%)  1 0/39 (0.00%)  0
MENTAL DETERIORATION  1  0/75 (0.00%)  0 1/39 (2.56%)  1
SYNCOPE  1  1/75 (1.33%)  2 0/39 (0.00%)  0
Psychiatric disorders     
MOOD ALTERED  1  0/75 (0.00%)  0 1/39 (2.56%)  1
Renal and urinary disorders     
HEMATURIA  1  1/75 (1.33%)  1 1/39 (2.56%)  1
HYDRONEPHROSIS  1  1/75 (1.33%)  1 0/39 (0.00%)  0
URINARY BLADDER OBSTRUCTION  1  1/75 (1.33%)  1 0/39 (0.00%)  0
URINARY INCONTINENCE  1  1/75 (1.33%)  1 0/39 (0.00%)  0
URINARY RETENTION  1  0/75 (0.00%)  0 1/39 (2.56%)  1
Respiratory, thoracic and mediastinal disorders     
DISTRESS RESPIRATORY  1  0/75 (0.00%)  0 1/39 (2.56%)  1
EFFUSION PLEURAL  1  2/75 (2.67%)  2 0/39 (0.00%)  0
EMBOLISM PULMONARY  1  1/75 (1.33%)  1 2/39 (5.13%)  2
EMBOLUS PULMONARY  1  0/75 (0.00%)  0 1/39 (2.56%)  1
PLEURAL EFFUSION  1  1/75 (1.33%)  1 1/39 (2.56%)  1
PNEUMONIA  1  2/75 (2.67%)  2 2/39 (5.13%)  2
RESPIRATORY FAILURE  1  0/75 (0.00%)  0 1/39 (2.56%)  1
SHORTNESS OF BREATH  1  1/75 (1.33%)  1 2/39 (5.13%)  2
TRACHEOBRONCHITIS  1  1/75 (1.33%)  1 0/39 (0.00%)  0
Vascular disorders     
ACCIDENT CEREBROVASCULAR  1  0/75 (0.00%)  0 1/39 (2.56%)  1
CARDIAC ARREST  1  1/75 (1.33%)  1 1/39 (2.56%)  1
CONGESTIVE HEART FAILURE  1  1/75 (1.33%)  1 0/39 (0.00%)  0
HYPOTENSION  1  1/75 (1.33%)  1 0/39 (0.00%)  0
PHLEBITIS  1  1/75 (1.33%)  1 0/39 (0.00%)  0
STROKE  1  1/75 (1.33%)  1 0/39 (0.00%)  0
THROMBOSIS  1  1/75 (1.33%)  1 2/39 (5.13%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART, CTCAE 3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1 Arm 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   74/75 (98.67%)      39/39 (100.00%)    
Blood and lymphatic system disorders     
NEUTROPENIA  1  48/75 (64.00%)  139 14/39 (35.90%)  35
LEUCOPENIA  1  27/75 (36.00%)  141 10/39 (25.64%)  23
ANEMIA  1  24/75 (32.00%)  50 15/39 (38.46%)  41
THROMBOCYTOPENIA  1  17/75 (22.67%)  56 8/39 (20.51%)  14
EDEMA  1  13/75 (17.33%)  15 7/39 (17.95%)  8
LYMPHOPENIA  1  5/75 (6.67%)  37 1/39 (2.56%)  1
Cardiac disorders     
CARDIAC INSUFFICIENCY  1  1/75 (1.33%)  1 4/39 (10.26%)  4
Eye disorders     
CONJUNCTIVITIS  1  5/75 (6.67%)  6 1/39 (2.56%)  1
EPIPHORA  1  4/75 (5.33%)  4 0/39 (0.00%)  0
Gastrointestinal disorders     
NAUSEA  1  17/75 (22.67%)  29 11/39 (28.21%)  13
ANOREXIA  1  17/75 (22.67%)  19 10/39 (25.64%)  11
CONSTIPATION  1  16/75 (21.33%)  20 9/39 (23.08%)  9
DIARRHEA  1  14/75 (18.67%)  22 9/39 (23.08%)  10
VOMITING  1  12/75 (16.00%)  19 9/39 (23.08%)  10
MUCOSITIS  1  9/75 (12.00%)  14 4/39 (10.26%)  4
GASTROESOPHAGEAL REFLUX  1  7/75 (9.33%)  11 4/39 (10.26%)  4
DEHYDRATION  1  5/75 (6.67%)  9 4/39 (10.26%)  4
ABDOMINAL PAIN  1  3/75 (4.00%)  3 5/39 (12.82%)  5
DYSGUESIA  1  1/75 (1.33%)  1 3/39 (7.69%)  3
DRY MOUTH  1  1/75 (1.33%)  1 2/39 (5.13%)  2
RECTAL BLEEDING  1  1/75 (1.33%)  1 2/39 (5.13%)  3
General disorders     
FATIGUE  1  36/75 (48.00%)  50 22/39 (56.41%)  34
PAIN  1  24/75 (32.00%)  35 12/39 (30.77%)  17
WEAKNESS  1  9/75 (12.00%)  10 3/39 (7.69%)  3
WEIGHT LOSS  1  6/75 (8.00%)  6 2/39 (5.13%)  2
CHILLS  1  5/75 (6.67%)  5 1/39 (2.56%)  3
MUSCLE WEAKNESS  1  5/75 (6.67%)  9 1/39 (2.56%)  1
CHEST PAIN  1  4/75 (5.33%)  4 0/39 (0.00%)  0
Immune system disorders     
ALLERGIC REACTION  1  7/75 (9.33%)  8 2/39 (5.13%)  2
Infections and infestations     
INFECTION BACTERIAL  1  10/75 (13.33%)  13 1/39 (2.56%)  1
FEVER  1  9/75 (12.00%)  10 2/39 (5.13%)  2
INFECTION FUNGAL  1  5/75 (6.67%)  9 1/39 (2.56%)  1
INFECTION BLADDER  1  4/75 (5.33%)  6 3/39 (7.69%)  3
CELLULITIS  1  4/75 (5.33%)  7 2/39 (5.13%)  2
Metabolism and nutrition disorders     
HYPOMAGNESAEMIA  1  23/75 (30.67%)  58 4/39 (10.26%)  4
HYPOKALAEMIA  1  11/75 (14.67%)  19 6/39 (15.38%)  9
HYPERGLYCEMIA  1  6/75 (8.00%)  15 9/39 (23.08%)  19
HYPOCALCEMIA  1  5/75 (6.67%)  6 2/39 (5.13%)  2
ALKALINE PHOSPHASTASE SERUM INCREASE  1  4/75 (5.33%)  4 4/39 (10.26%)  8
GLUCOSE BLOOD INCREASED  1  4/75 (5.33%)  8 0/39 (0.00%)  0
ALT INCREASED  1  3/75 (4.00%)  5 2/39 (5.13%)  6
AST INCREASED  1  3/75 (4.00%)  7 2/39 (5.13%)  4
CREATININE SERUM INCREASED  1  3/75 (4.00%)  9 2/39 (5.13%)  3
HYPERKALEMIA  1  1/75 (1.33%)  1 2/39 (5.13%)  3
Musculoskeletal and connective tissue disorders     
PAIN BACK  1  9/75 (12.00%)  13 6/39 (15.38%)  8
MYALGIA  1  6/75 (8.00%)  9 2/39 (5.13%)  2
ARTHRALGIA  1  3/75 (4.00%)  4 3/39 (7.69%)  3
SHOULDER PAIN  1  2/75 (2.67%)  2 3/39 (7.69%)  3
BRUISE  1  0/75 (0.00%)  0 2/39 (5.13%)  2
Nervous system disorders     
DIZZINESS  1  12/75 (16.00%)  18 7/39 (17.95%)  9
INSOMNIA  1  6/75 (8.00%)  6 2/39 (5.13%)  2
HEADACHE  1  5/75 (6.67%)  5 5/39 (12.82%)  5
NEUROPATHY  1  5/75 (6.67%)  5 3/39 (7.69%)  3
Psychiatric disorders     
ANXIETY  1  4/75 (5.33%)  4 0/39 (0.00%)  0
Renal and urinary disorders     
HEMATURIA  1  5/75 (6.67%)  6 2/39 (5.13%)  3
URINARY URGENCY/FREQUENCY  1  4/75 (5.33%)  4 1/39 (2.56%)  1
URINARY INCONTINENCE  1  0/75 (0.00%)  0 2/39 (5.13%)  2
Respiratory, thoracic and mediastinal disorders     
COUGH  1  11/75 (14.67%)  13 4/39 (10.26%)  4
SHORTNESS OF BREATH  1  10/75 (13.33%)  13 4/39 (10.26%)  5
INFECTION UPPER RESPIRATORY  1  6/75 (8.00%)  6 2/39 (5.13%)  2
PHARYNGITIS  1  4/75 (5.33%)  4 0/39 (0.00%)  0
Skin and subcutaneous tissue disorders     
RASH  1  25/75 (33.33%)  63 3/39 (7.69%)  3
DRY SKIN  1  17/75 (22.67%)  26 4/39 (10.26%)  4
NAIL DISORDER  1  5/75 (6.67%)  5 0/39 (0.00%)  0
ALOPECIA  1  4/75 (5.33%)  4 4/39 (10.26%)  4
Vascular disorders     
HYPOTENSION  1  2/75 (2.67%)  3 2/39 (5.13%)  2
THROMBOSIS  1  2/75 (2.67%)  2 2/39 (5.13%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART, CTCAE 3.0
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: Dr. Mark T. Fleming
Organization: US Oncology
Phone: 757-827-9400
Responsible Party: US Oncology Research
ClinicalTrials.gov Identifier: NCT00661492     History of Changes
Other Study ID Numbers: 06-118
First Submitted: April 4, 2008
First Posted: April 18, 2008
Results First Submitted: July 31, 2013
Results First Posted: December 9, 2016
Last Update Posted: December 9, 2016