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Panitumumab and Irinotecan for Malignant Gliomas

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ClinicalTrials.gov Identifier: NCT01017653
Recruitment Status : Terminated (study did not reach benchmark efficacy rule at 16 subjects)
First Posted : November 20, 2009
Results First Posted : September 4, 2013
Last Update Posted : September 4, 2013
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Annick Desjardins, Duke University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Malignant Glioma of Brain
Interventions Drug: Irinotecan
Drug: Panitumumab
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Panitumumab and Irinotecan
Hide Arm/Group Description Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
Period Title: Overall Study
Started 16
Completed 16
Not Completed 0
Arm/Group Title Panitumumab and Irinotecan
Hide Arm/Group Description Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
48.73  (14.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
3
  18.8%
Male
13
  81.3%
1.Primary Outcome
Title 6-month Progression-free Survival (PFS)
Hide Description Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause. Macdonald criteria are standard criteria in neuro-oncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of: 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), and 3) concomitant steroid use (as reported by the investigator).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Panitumumab and Irinotecan
Hide Arm/Group Description:
Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
Overall Number of Participants Analyzed 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.5
(2.1 to 32.8)
2.Secondary Outcome
Title One-Year Overall Survival
Hide Description Percentage of participants surviving 12 months from the start of study treatment. OS was defined as the time from the date of study treatment initiation to the date of the death due to any cause.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Panitumumab and Irinotecan
Hide Arm/Group Description:
Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
Overall Number of Participants Analyzed 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.5
(2.1 to 32.8)
3.Secondary Outcome
Title Safety of Panitumumab in Combination With Irinotecan
Hide Description Number of participants experiencing a toxicity ≥ grade 3 as graded per CTCAE v.3.0
Time Frame 16 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Panitumumab and Irinotecan
Hide Arm/Group Description:
Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: participants
10
4.Secondary Outcome
Title Effect of Panitumumab in Combination With Irinotecan on Corticosteroid Dose
Hide Description Average change in corticosteroid dose from baseline to the end of cycle 1.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Insufficient data to analyze the effect of the treatment regimen on corticosteroid dose. Data was not collected for this outcome.
Arm/Group Title Panitumumab and Irinotecan
Hide Arm/Group Description:
Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: mg
NA [1] 
[1]
Insufficient data to analyze the effect of the treatment regimen on corticosteroid dose. Data was not collected for this outcome.
5.Secondary Outcome
Title Relationship Between Epidermal Growth Factor Receptor (EGF-R) Mutational Analysis and Efficacy or Toxicity
Hide Description Number of participants with an abnormal fluorescence in situ hybridization (FISH) interpretation that 1) survived < 6 months and 2) experienced a ≥ grade 3 toxicity as graded per CTCAE v.3.0
Time Frame 16 months
Hide Outcome Measure Data
Hide Analysis Population Description
Insufficient data to analyze the relationship between EGF-R analysis and efficacy or toxicity. Data was not collected for this outcome.
Arm/Group Title Panitumumab and Irinotecan
Hide Arm/Group Description:
Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: participants
Abnormal FISH Interpretation & Survived <6 months NA [1] 
Abnormal FISH Interpretation & ≥ grade 3 toxicity NA [1] 
[1]
Insufficient data to analyze the relationship between EGF-R analysis and efficacy or toxicity
6.Secondary Outcome
Title Objective Response Rate
Hide Description Number of participants with an objective response (complete response or partial response) based on modified Macdonald criteria. A complete response is defined as the disappearance of all enhancing rumor and mass effect, off all corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks. A partial response is defined as greater than or equal to 50% reduction in tumor size on MR (magnetic resonance) / CT(computed tomography) by bi-dimensional measurement on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks.
Time Frame 16 months
Hide Outcome Measure Data
Hide Analysis Population Description
2 patients' response was unknown due to withdrawal from the study before an MRI was performed.
Arm/Group Title Panitumumab and Irinotecan
Hide Arm/Group Description:
Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: participants
0
7.Secondary Outcome
Title Median Overall Survival (OS)
Hide Description Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Panitumumab and Irinotecan
Hide Arm/Group Description:
Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
Overall Number of Participants Analyzed 16
Median (95% Confidence Interval)
Unit of Measure: months
4.6
(4.0 to 5.8)
Time Frame 16 months
Adverse Event Reporting Description The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
 
Arm/Group Title Panitumumab and Irinotecan
Hide Arm/Group Description Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
All-Cause Mortality
Panitumumab and Irinotecan
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Panitumumab and Irinotecan
Affected / at Risk (%)
Total   1/16 (6.25%) 
Nervous system disorders   
Intracranial hemorrhage  1  1/16 (6.25%) 
Ischemia cerebrovascular  1  1/16 (6.25%) 
Seizure  1  1/16 (6.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Panitumumab and Irinotecan
Affected / at Risk (%)
Total   16/16 (100.00%) 
Ear and labyrinth disorders   
"Ear and labyrinth disorders - Other, specify: Pop noise in ears"  1  1/16 (6.25%) 
Eye disorders   
Blurred vision  1  1/16 (6.25%) 
Optic nerve disorder  1  2/16 (12.50%) 
Gastrointestinal disorders   
Constipation  1  5/16 (31.25%) 
Diarrhea  1  3/16 (18.75%) 
"Gastrointestinal disorders - Other, specify: Acid Reflux"  1  3/16 (18.75%) 
Mucositis oral  1  1/16 (6.25%) 
Nausea  1  5/16 (31.25%) 
Vomiting  1  4/16 (25.00%) 
General disorders   
Chills  1  1/16 (6.25%) 
Edema limbs  1  2/16 (12.50%) 
Fatigue  1  13/16 (81.25%) 
Fever  1  1/16 (6.25%) 
Infections and infestations   
Lung infection  1  1/16 (6.25%) 
Nail infection  1  4/16 (25.00%) 
Scrotal infection  1  1/16 (6.25%) 
Investigations   
Alanine aminotransferase increased  1  2/16 (12.50%) 
Neutrophil count decreased  1  1/16 (6.25%) 
Metabolism and nutrition disorders   
Anorexia  1  4/16 (25.00%) 
Dehydration  1  3/16 (18.75%) 
Hyperglycemia  1  3/16 (18.75%) 
Hypokalemia  1  1/16 (6.25%) 
Hypomagnesemia  1  3/16 (18.75%) 
Musculoskeletal and connective tissue disorders   
Generalized muscle weakness  1  1/16 (6.25%) 
Muscle weakness left-sided  1  2/16 (12.50%) 
Muscle weakness right-sided  1  2/16 (12.50%) 
"Musculoskeletal and connective tissue disorder - Other, specify: Fall"  1  4/16 (25.00%) 
Nervous system disorders   
Ataxia  1  3/16 (18.75%) 
Cognitive disturbance  1  1/16 (6.25%) 
Dysgeusia  1  1/16 (6.25%) 
Dysphasia  1  3/16 (18.75%) 
"Nervous system disorders - Other, specify: Concentration impairment"  1  1/16 (6.25%) 
"Nervous system disorders - Other, specify: Gait"  1  2/16 (12.50%) 
Pyramidal tract syndrome  1  2/16 (12.50%) 
Seizure  1  5/16 (31.25%) 
Psychiatric disorders   
Confusion  1  1/16 (6.25%) 
Depression  1  1/16 (6.25%) 
Insomnia  1  1/16 (6.25%) 
Renal and urinary disorders   
Urinary incontinence  1  2/16 (12.50%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/16 (6.25%) 
Voice alteration  1  1/16 (6.25%) 
Skin and subcutaneous tissue disorders   
Dry skin  1  3/16 (18.75%) 
Pruritus  1  4/16 (25.00%) 
Rash acneiform  1  9/16 (56.25%) 
Rash maculo-papular  1  9/16 (56.25%) 
"Skin and subcutaneous tissue disorders - Other, specify: Cuticle cuts/open wounds"  1  1/16 (6.25%) 
Skin and subcutaneous tissue disorders-Other, specify: Increased hair growth  1  1/16 (6.25%) 
"Skin and subcutaneous tissue disorders - Other, specify: Laceration, head"  1  1/16 (6.25%) 
Vascular disorders   
Thromboembolic event  1  1/16 (6.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Annick Desjardins
Organization: Preston Robert Tisch Brain Tumor Center
Responsible Party: Annick Desjardins, Duke University
ClinicalTrials.gov Identifier: NCT01017653     History of Changes
Other Study ID Numbers: Pro00015447
First Submitted: November 19, 2009
First Posted: November 20, 2009
Results First Submitted: April 30, 2013
Results First Posted: September 4, 2013
Last Update Posted: September 4, 2013