Overview

This trial is active, not recruiting.

Condition metastatic colorectal cancer
Treatments cetuximab, panitumumab
Phase phase 3
Target EGFR
Sponsor Amgen
Start date February 2010
End date February 2013
Trial size 1010 participants
Trial identifier NCT01001377, 20080763, 2009-010715-32, ASPECCT

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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.
cetuximab Erbitux
Administered by intravenous infusion
(Experimental)
Panitumumab 6 mg/kg IV every 14 days. Participants were treated until disease progression, intolerability, withdrawal of consent, or death.
panitumumab Vectibix
Administered by intravenous infusion

Primary Outcomes

Measure
Overall Survival
time frame: From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.

Secondary Outcomes

Measure
Progression-free Survival
time frame: From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Objective 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
time frame: From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
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 Treatment Failure
time frame: From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
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.
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.
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.
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.
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.
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.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Amgen.