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ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT01001377
Recruitment Status : Completed
First Posted : October 26, 2009
Results First Posted : March 24, 2014
Last Update Posted : September 21, 2022
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
The primary objective of this study is to compare the effect of panitumumab versus cetuximab on overall survival (OS) for chemorefractory metastatic colorectal cancer (mCRC) among patients with wild-type Kirsten rat Sarcoma-2 virus (KRAS) tumors.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Cetuximab Drug: Panitumumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1010 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Open-label, Phase 3 Study to Compare the Efficacy and Safety of Panitumumab and Cetuximab in Subjects With Previously Treated, Wild-type KRAS, Metastatic Colorectal Cancer
Actual Study Start Date : February 2, 2010
Actual Primary Completion Date : February 5, 2013
Actual Study Completion Date : March 7, 2017

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Cetuximab

Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.

Participants were treated until disease progression, intolerability, withdrawal of consent, or death.

 Drug: Cetuximab
Administered by intravenous infusion
Other Name: Erbitux
Experimental: Panitumumab
Panitumumab 6 mg/kg IV every 14 days. Participants were treated until disease progression, intolerability, withdrawal of consent, or death.
 Drug: Panitumumab
Administered by intravenous infusion
Other Name: Vectibix


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. ]
    Overall survival is the time from the date of randomization until the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date.


Secondary Outcome Measures :
  1. Progression-free Survival [ Time Frame: From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. ]

    Progression free survival (PFS) is the time from the date of randomization to the date of disease progression per the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death. Participants alive and not meeting criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date.

    Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study based on all target lesions recorded since the treatment started (the sum must also demonstrate an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or any new lesions.


  2. Objective Response [ Time Frame: From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. ]
    Objective response is either a complete response (CR) or partial response (PR) per RECIST version 1.1. All participants that did not meet the criteria for an objective response by the analysis cut-off date were considered non-responders. CR: Disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, and disappearance of all non-target lesions, and no new lesions. PR: Disappearance of all target lesions, persistence of one or more non-target lesions not qualifying for either CR or progressive disease, or, at least a 30% decrease in the sum of diameters of target lesions with no unequivocal progression of existing non-target lesions and no new lesions.

  3. Duration of Response [ Time Frame: From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. ]
    Duration of response (DOR), calculated only for those participants with an objective response, is the time from first objective response to disease progression per the RECIST v1.1 or death. Participants not meeting criteria for progression or who died by the analysis data cutoff date were censored at their last evaluable disease assessment date.

  4. Time to Response [ Time Frame: From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. ]
    Time to response (TTR), calculated for those participants with an objective response, is defined as the time from the randomization date to the date of first objective response.

  5. Time to Treatment Failure [ Time Frame: From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. ]
    Time to treatment failure (TTF) is the time from randomization date to date that the decision was made to end the treatment period for any reason; participants who remained in the treatment period at the time of analysis were censored at the date of the last on-study assessment.

  6. Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Health State Index Score [ Time Frame: From Study Day 1 through the last day of treatment or disease progression, up to Week 85. ]
    The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The health state index measures the following 5 health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension contains 3 levels of response to reflect degree of problems participants have experienced: no problem (1), some problem (2) and extreme problems (3). The health states for each respondent are converted into a single index number using a specified set of weights. Resulting scores can range from 1.0 and -0.594. A higher score indicates a more preferred health status with 1.0 representing perfect health and 0 representing death. Negative scores are possible and represent health states regarded as less preferable than death (0). Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and participants a random effect.

  7. Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Visual Analog Scale (VAS) [ Time Frame: From Study Day 1 through the last day of treatment or disease progression, up to Week 85. ]
    The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The VAS asks respondents to rate their present health status on a 0 - 100 scale, with 0 labeled as "Worst imaginable health state" and 100 labeled as "Best imaginable health state." The VAS score is determined by observing the point at which the participant's hand drawn line intersects the scale.

  8. Change From Baseline in National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Colorectal Symptom Index (NCCN FCSI ) Symptoms Score [ Time Frame: From Study Day 1 through the last day of treatment or disease progression, up to Week 85. ]
    The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).

  9. Change From Baseline in NCCN FCSI Physical Well-being Scale Score [ Time Frame: From Study Day 1 through the last day of treatment or disease progression, up to Week 85. ]
    The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).

  10. Change From Baseline in NCCN FCSI Functional Well-being Scale Score [ Time Frame: From Study Day 1 through the last day of treatment or disease progression, up to Week 85. ]
    The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).

  11. Number of Participants With Adverse Events (AEs) [ Time Frame: From the day of the first dose of study therapy through 30 days since the last dose. Maximum time on study treatment was 130 weeks. ]
    Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related AEs are those the investigator considered as a reasonable possibility to have been caused by study drug.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum, metastatic disease
  • Wild-type KRAS tumor status
  • Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2
  • Must have failed a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease
  • Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of colorectal cancer (CRC)
  • Adequate hematologic, renal, hepatic and metabolic function

Exclusion Criteria:

  • Symptomatic brain metastases requiring treatment
  • Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, panitumumab or cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib)
  • Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy), or investigational agent or therapy ≤ 30 days before randomization.
  • Clinically significant cardiovascular disease
  • Active infection requiring systemic treatment or any uncontrolled infection ≤14 days prior to randomization
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01001377


Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01001377    
Other Study ID Numbers: 20080763
ASPECCT
2009-010715-32 ( EudraCT Number )
First Posted: October 26, 2009    Key Record Dates
Results First Posted: March 24, 2014
Last Update Posted: September 21, 2022
Last Verified: September 2022
Keywords provided by Amgen:
Panitumumab
Vectibix
Colon Cancer
Colorectal Cancer
 Rectal Cancer
Cetuximab
Erbitux
Metastatic
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Panitumumab
Antineoplastic Agents, Immunological
Antineoplastic Agents