None listed
Conditions
Interventions
Group 1 Type of group
Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
Group name:Group 2 Type of group
Panitumumab 6 mg/kg IV every 14 days. Participants were treated until disease progression, intolerability, withdrawal of consent, or death.
Sponsors
AMGEN INC.,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum Metastatic disease • Wild-type KRAS tumor status by protocol-specified testing (see Section 7.10) Formalin-fixed paraffin-embedded tumor tissue from either the primary tumor or a metastatic lesion must be submitted for biomarker testing (see Section 7.10) • ECOG performance status of 0, 1 or 2 • Measurable or non-measurable disease per RECIST version 1.1 • Must have failed a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease. Oxaliplatin and irinotecan may have been administered sequentially or in combination. Failure is defined as either disease progression (clinical or radiological) or intolerance to the regimen • Subjects in whom relapse is diagnosed within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will be considered as having failed a prior regimen for metastatic disease • Must have previously received a thymidylate synthase inhibitor (e.g. fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of CRC • Man or woman = 18 years of age • Hematologic function, as follows: (= 10 days prior to randomization) Absolute neutrophil count (ANC) = 1.5 x 10 to the power of 9/L. Platelet count = 75 x 10 to the power of 9/L. Hemoglobin = 8.0 g/dL. Renal function, as follows: (= 10 days prior to randomization). Creatinine = 1.5 x ULN • Hepatic function, as follows: (= 10 days prior to randomization). Aspartate aminotransferase (AST) = 3 x ULN (if liver metastases = 5 x ULN). Alanine aminotransferase (ALT) = 3 x ULN (if liver metastases = 5 x ULN). Total bilirubin = 1.5 x ULN • Metabolic function, as follows: (= 10 days prior to randomization). Magnesium = lower limit of normal • Negative pregnancy test = 72 hours before randomization (for women of childbearing potential only) • Competent to comprehend, sign, and date a written IEC/IRB approved informed consent form before any study-specific procedure
Exclusion criteria
Exclusion criteria: • Symptomatic brain metastases requiring treatment • History of other malignancy, except: • Malignancy treated with curative intent and with no known active disease present for = 5 years prior to randomization and felt to be at low risk for recurrence by the treating physician. Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease. Adequately treated cervical carcinoma in situ without evidence of disease. Prostatic intraepithelial neoplasia without evidence of prostate cancer • Known hypersensitivity to any of the protocol-specified agents or their excipients • Prior anti-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. Subjects must have recovered from any acute toxicity • Subject previously randomized to this study • Other investigational procedures = 30 days before randomization • Subject currently is enrolled in or = 30 days from ending other investigational device or drug study(s) • Major surgery (eg, requiring general anesthesia) = 28 days before randomization. Subjects must have recovered from any surgery related toxicities • Clinically significant cardiovascular disease (as defined by: unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) • Myocardial infarction within last 6 months before randomization • History of interstitial lung disease (ILD), eg, interstitial pneumonitis, pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT or MRI • History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results • Subject pregnant or breast feeding, or planning to become pregnant during treatment and within 6 months after the end of treatment • Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for an additional 6 months (males and females) after the end of treatment • Known positive test(s) for human immunodeficiency virus infection (testing is not required in the absence of clinical suspicion) • Active infection requiring systemic treatment or any uncontrolled infections =14 days prior to randomization • Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures or is unwilling or unable to comply with study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name: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. Measure:Overall Survival Timepoints:From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name: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. Measure:Progression-free Survival Timepoints:From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. ; Outcome name: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. Measure:Objective Response Timepoints:From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks ; Outcome name: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 d | — |
Countries
Australia, Belgium, Bulgaria, Canada, China, Czech Republic, France, Hong Kong, India, Israel, Italy, Latovia, Lithuania, Malasya, Mexico, Netherlands, Philippines, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Sweden, Taiwan, Turkey, United Kindgdom, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed