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Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer

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: NCT00089635
Recruitment Status : Completed
First Posted : August 11, 2004
Results First Posted : December 5, 2013
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Colorectal Cancer
Metastases
Intervention Drug: Panitumumab
Enrollment 203
Recruitment Details Participants were enrolled from 11 August 2004 through 2 August 2006
Pre-assignment Details  
Arm/Group Title Panitumumab
Hide Arm/Group Description Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Period Title: Overall Study
Started 203
Completed 160
Not Completed 43
Reason Not Completed
Adverse Event             2
Death             17
Disease Progression             12
Lost to Follow-up             3
Withdrawal by Subject             6
Ineligibility determined             1
Other             2
Arm/Group Title Panitumumab
Hide Arm/Group Description Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Overall Number of Baseline Participants 203
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 203 participants
62
(54 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 203 participants
Female
89
  43.8%
Male
114
  56.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 203 participants
American Indian or Alaska Native 2
Asian 3
Black or African American 34
Hispanic or Latino 13
White or Caucasian 151
1.Primary Outcome
Title Objective Tumor Response Through Week 16
Hide Description Confirmed objective tumor response was defined as a complete response or partial response from enrollment through Week 16. Tumor response was monitored, beginning at Week 8, per a modified version of the World Health Organization (WHO) criteria for tumor response and progression by an independent review committee central assessment. Complete response was defined per modified WHO criteria as disappearance of all lesions (index and non-index). Partial response was defined as ≥ 50% decrease from Baseline in the sum of the products of the longest diameters (SPD) of index lesions. Scans were required to confirm a complete or partial response no earlier than 4 weeks from the time a response of complete or partial response was first documented.
Time Frame From enrollment through Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).
Arm/Group Title Panitumumab
Hide Arm/Group Description:
Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Overall Number of Participants Analyzed 158
Measure Type: Number
Unit of Measure: participants
6
2.Primary Outcome
Title Duration of Response
Hide Description Kaplan-Meier estimate of time time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever comes first) among participants who had a response at any time on study. Participants who responded and did not progress while on study or who died for reasons other than disease progression while on study were censored at their last evaluable assessment date.
Time Frame From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), who had a confirmed objective tumor response at any time on study.
Arm/Group Title Panitumumab
Hide Arm/Group Description:
Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Overall Number of Participants Analyzed 7
Median (95% Confidence Interval)
Unit of Measure: weeks
22.2
(16.1 to 28.4)
3.Secondary Outcome
Title Objective Tumor Response Throughout the Study
Hide Description Confirmed objective tumor response was defined as a complete response or partial response from enrollment through to the data cut-ff date. Tumor response was monitored, beginning at Week 8, per a modified version of the World Health Organization (WHO) criteria for tumor response and progression by an independent review committee central assessment. Complete response was defined per modified WHO criteria as disappearance of all lesions (index and non-index). Partial response was defined as ≥ 50% decrease from Baseline in the sum of the products of the longest diameters (SPD) of index lesions. Scans were required to confirm a complete or partial response no earlier than 4 weeks from the time a response of complete or partial response was first documented.
Time Frame From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).
Arm/Group Title Panitumumab
Hide Arm/Group Description:
Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Overall Number of Participants Analyzed 158
Measure Type: Number
Unit of Measure: participants
7
4.Secondary Outcome
Title Time to Initial Objective Response
Hide Description Time from date of enrollment to first objective response; participants with stable disease at their last evaluable assessment date were censored at this date and participants with progressive disease while on study were censored after the last response was observed for all participants.
Time Frame From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), who had an objective tumor response at any time on study.
Arm/Group Title Panitumumab
Hide Arm/Group Description:
Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Overall Number of Participants Analyzed 7
Median (Full Range)
Unit of Measure: weeks
11
(7 to 23)
5.Secondary Outcome
Title Progression-free Survival Time
Hide Description Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death (whichever comes first); participants who did not progress while on study and did not die while on study were censored at their last evaluable assessment date.
Time Frame From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).
Arm/Group Title Panitumumab
Hide Arm/Group Description:
Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Overall Number of Participants Analyzed 158
Median (95% Confidence Interval)
Unit of Measure: weeks
8.1
(7.4 to 11.3)
6.Secondary Outcome
Title Time to Disease Progression
Hide Description Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death date if the death was due to disease progression (whichever comes first); participants who have not progressed while on study or died for reasons other than disease progression while on study were censored at their last evaluable assessment date.
Time Frame From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).
Arm/Group Title Panitumumab
Hide Arm/Group Description:
Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Overall Number of Participants Analyzed 158
Median (95% Confidence Interval)
Unit of Measure: weeks
8.3
(7.4 to 11.3)
7.Secondary Outcome
Title Time to Treatment Failure
Hide Description Kaplan-Meier estimate of median time from date of enrollment to date decision was made to end the treatment phase for any reason; participants who complete the treatment phase or who remain in the treatment phase at the completion of the study were censored at this time.
Time Frame From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), for whom a decision was made to end treatment for any reason.
Arm/Group Title Panitumumab
Hide Arm/Group Description:
Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Overall Number of Participants Analyzed 158
Median (95% Confidence Interval)
Unit of Measure: weeks
8.4
(8.1 to 11.3)
8.Secondary Outcome
Title Duration of Stable Disease
Hide Description

Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death date if the death was due to disease progression (whichever comes first); in those participants who had a best response of stable disease.

Stable Disease is defined as neither sufficient shrinkage of index lesions to qualify for a partial response nor sufficient increase to qualify for progressive disease taking as reference the nadir sum of the products of the longest diameters since the treatment started.

Time Frame From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), who had a best response of stable disease.
Arm/Group Title Panitumumab
Hide Arm/Group Description:
Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Overall Number of Participants Analyzed 52
Median (95% Confidence Interval)
Unit of Measure: weeks
16.0
(15.3 to 22.9)
9.Secondary Outcome
Title Overall Survival
Hide Description Kaplan-Meier estimate of time to death from any cause; participants who had not died while on study or were lost to follow-up were censored at their last contact date.
Time Frame From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).
Arm/Group Title Panitumumab
Hide Arm/Group Description:
Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Overall Number of Participants Analyzed 158
Median (95% Confidence Interval)
Unit of Measure: months
9.0
(8.1 to 11.2)
Time Frame First dose date through the safety follow-up visit. The median time frame is 2.6 months.
Adverse Event Reporting Description The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
 
Arm/Group Title Panitumumab
Hide Arm/Group Description Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
All-Cause Mortality
Panitumumab
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Panitumumab
Affected / at Risk (%)
Total   61/203 (30.05%) 
Blood and lymphatic system disorders   
Anaemia  1  3/203 (1.48%) 
Lymphadenopathy  1  1/203 (0.49%) 
Cardiac disorders   
Acute myocardial infarction  1  1/203 (0.49%) 
Angina unstable  1  1/203 (0.49%) 
Myocardial infarction  1  2/203 (0.99%) 
Gastrointestinal disorders   
Abdominal discomfort  1  1/203 (0.49%) 
Abdominal pain  1  6/203 (2.96%) 
Abdominal pain upper  1  3/203 (1.48%) 
Ascites  1  2/203 (0.99%) 
Constipation  1  2/203 (0.99%) 
Diarrhoea  1  1/203 (0.49%) 
Gastritis  1  1/203 (0.49%) 
Haematochezia  1  1/203 (0.49%) 
Nausea  1  4/203 (1.97%) 
Pancreatitis  1  2/203 (0.99%) 
Small intestinal obstruction  1  2/203 (0.99%) 
Vomiting  1  2/203 (0.99%) 
General disorders   
Chills  1  1/203 (0.49%) 
Infusion related reaction  1  2/203 (0.99%) 
Pyrexia  1  4/203 (1.97%) 
Hepatobiliary disorders   
Bile duct obstruction  1  1/203 (0.49%) 
Hyperbilirubinaemia  1  2/203 (0.99%) 
Immune system disorders   
Anaphylactic reaction  1  1/203 (0.49%) 
Hypersensitivity  1  1/203 (0.49%) 
Infections and infestations   
Cellulitis  1  1/203 (0.49%) 
Gastroenteritis  1  1/203 (0.49%) 
Klebsiella bacteraemia  1  1/203 (0.49%) 
Pneumonia  1  1/203 (0.49%) 
Pyelonephritis  1  1/203 (0.49%) 
Injury, poisoning and procedural complications   
Compression fracture  1  1/203 (0.49%) 
Exposure to toxic agent  1  1/203 (0.49%) 
Incisional hernia  1  1/203 (0.49%) 
Pelvic fracture  1  1/203 (0.49%) 
Investigations   
Prothrombin time prolonged  1  1/203 (0.49%) 
Urine output decreased  1  1/203 (0.49%) 
Metabolism and nutrition disorders   
Dehydration  1  6/203 (2.96%) 
Failure to thrive  1  1/203 (0.49%) 
Hyperkalaemia  1  3/203 (1.48%) 
Hypocalcaemia  1  1/203 (0.49%) 
Hypoglycaemia  1  1/203 (0.49%) 
Hypokalaemia  1  2/203 (0.99%) 
Hypomagnesaemia  1  2/203 (0.99%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  4/203 (1.97%) 
Musculoskeletal chest pain  1  2/203 (0.99%) 
Musculoskeletal pain  1  1/203 (0.49%) 
Pain in extremity  1  1/203 (0.49%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Brain neoplasm  1  1/203 (0.49%) 
Colon cancer  1  6/203 (2.96%) 
Colon cancer metastatic  1  5/203 (2.46%) 
Colorectal cancer  1  6/203 (2.96%) 
Colorectal cancer metastatic  1  4/203 (1.97%) 
Nervous system disorders   
Cerebrovascular accident  1  1/203 (0.49%) 
Convulsion  1  2/203 (0.99%) 
Depressed level of consciousness  1  1/203 (0.49%) 
Spinal cord compression  1  2/203 (0.99%) 
Tremor  1  1/203 (0.49%) 
Psychiatric disorders   
Confusional state  1  1/203 (0.49%) 
Hallucination  1  1/203 (0.49%) 
Renal and urinary disorders   
Renal failure  1  1/203 (0.49%) 
Renal failure acute  1  1/203 (0.49%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  2/203 (0.99%) 
Chronic obstructive pulmonary disease  1  1/203 (0.49%) 
Dyspnoea  1  6/203 (2.96%) 
Pleural effusion  1  3/203 (1.48%) 
Respiratory distress  1  1/203 (0.49%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Panitumumab
Affected / at Risk (%)
Total   200/203 (98.52%) 
Blood and lymphatic system disorders   
ANAEMIA  1  14/203 (6.90%) 
Eye disorders   
CONJUNCTIVITIS  1  11/203 (5.42%) 
Gastrointestinal disorders   
ABDOMINAL DISTENSION  1  13/203 (6.40%) 
ABDOMINAL PAIN  1  31/203 (15.27%) 
ABDOMINAL PAIN UPPER  1  14/203 (6.90%) 
CONSTIPATION  1  34/203 (16.75%) 
DIARRHOEA  1  55/203 (27.09%) 
NAUSEA  1  68/203 (33.50%) 
STOMATITIS  1  15/203 (7.39%) 
VOMITING  1  53/203 (26.11%) 
General disorders   
ASTHENIA  1  19/203 (9.36%) 
FATIGUE  1  71/203 (34.98%) 
OEDEMA PERIPHERAL  1  26/203 (12.81%) 
PYREXIA  1  19/203 (9.36%) 
Infections and infestations   
PARONYCHIA  1  42/203 (20.69%) 
RASH PUSTULAR  1  18/203 (8.87%) 
UPPER RESPIRATORY TRACT INFECTION  1  11/203 (5.42%) 
Investigations   
WEIGHT DECREASED  1  24/203 (11.82%) 
Metabolism and nutrition disorders   
ANOREXIA  1  44/203 (21.67%) 
DEHYDRATION  1  13/203 (6.40%) 
HYPOCALCAEMIA  1  11/203 (5.42%) 
HYPOKALAEMIA  1  14/203 (6.90%) 
HYPOMAGNESAEMIA  1  28/203 (13.79%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  15/203 (7.39%) 
BACK PAIN  1  21/203 (10.34%) 
Nervous system disorders   
DIZZINESS  1  14/203 (6.90%) 
HEADACHE  1  18/203 (8.87%) 
NEUROPATHY PERIPHERAL  1  11/203 (5.42%) 
Psychiatric disorders   
ANXIETY  1  14/203 (6.90%) 
DEPRESSION  1  11/203 (5.42%) 
INSOMNIA  1  19/203 (9.36%) 
Respiratory, thoracic and mediastinal disorders   
COUGH  1  28/203 (13.79%) 
DYSPNOEA  1  33/203 (16.26%) 
Skin and subcutaneous tissue disorders   
ACNE  1  11/203 (5.42%) 
DERMATITIS ACNEIFORM  1  141/203 (69.46%) 
DRY SKIN  1  41/203 (20.20%) 
ERYTHEMA  1  137/203 (67.49%) 
EXFOLIATIVE RASH  1  48/203 (23.65%) 
NAIL DISORDER  1  12/203 (5.91%) 
PRURITUS  1  140/203 (68.97%) 
RASH  1  59/203 (29.06%) 
RASH PAPULAR  1  14/203 (6.90%) 
SKIN EXFOLIATION  1  23/203 (11.33%) 
SKIN FISSURES  1  31/203 (15.27%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00089635    
Obsolete Identifiers: NCT00112944
Other Study ID Numbers: 20030250
First Submitted: August 9, 2004
First Posted: August 11, 2004
Results First Submitted: August 6, 2010
Results First Posted: December 5, 2013
Last Update Posted: October 17, 2018