A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of Panitumumab in Combination with Oxaliplatin/ 5-fluorouracil/ leucovorin to the Efficacy of Oxaliplatin/ 5-fluorouracil/ leucovorin Alone in Patients with Previously Untreated Metastatic Colorectal Cancer

• Register: EUCTR
• Last refreshed on: 25 February 2013
• Main ID: EUCTR2006-000170-70-HU
• Date of registration: 03/05/2006
• Prospective Registration: Yes
• Primary sponsor: Amgen Inc
• Public title: A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of Panitumumab in Combination with Oxaliplatin/ 5-fluorouracil/ leucovorin to the Efficacy of Oxaliplatin/ 5-fluorouracil/ leucovorin Alone in Patients with Previously Untreated Metastatic Colorectal Cancer
• Scientific title: A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of Panitumumab in Combination with Oxaliplatin/ 5-fluorouracil/ leucovorin to the Efficacy of Oxaliplatin/ 5-fluorouracil/ leucovorin Alone in Patients with Previously Untreated Metastatic Colorectal Cancer
• Date of first enrolment: 10/07/2006
• Target sample size: 900
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000170-70
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Belgium, Czech Republic, Estonia, Hungary, Italy, Latvia, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
• Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum in
subjects who are presenting with metastatic disease
• At least 1 uni-dimensionally measurable lesion of at least 20mm per modified RECIST
guidelines (all sites of disease must be evaluated = 28 days prior to randomization)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Paraffin-embedded tumor tissue from the primary tumor or metastasis available for
central analyses of EGFr and biomarker testing
• Man or woman = 18 years of age
• Hematologic function, as follows (= 7 days prior to randomization):
o Absolute neutrophil count (ANC) = 1.5 x 109/L
o Platelet count = 100 x 109/L
o Hemoglobin = 9 g/dL
• Renal function, as follows (=7 days prior to randomization):
o Estimated creatinine clearance > 50 ml/min
• Hepatic function, as follows (=7 days prior to randomization):
o Aspartate aminotransferase (AST) = 3 x ULN (if liver metastases = 5 x ULN)
o Alanine aminotransferase (ALT) = 3 x ULN (if liver metastases = 5 x ULN)
o Total bilirubin = 1.5 x ULN
• Metabolic function, as follows (=7 days prior to randomization):
o Magnesium = lower limit of normal
• Negative pregnancy test = 72 hours prior to randomization (females of childbearing
potential only)
• Competent to comprehend, sign, and date an IEC/IRB-approved informed consent form
• Life expectancy = 3 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• History or known presence of central nervous system (CNS) metastases
• History of another primary cancer, except:
o Curatively treated in situ cervical cancer, or
o Curatively resected non-melanoma skin cancer, or
o Other primary solid tumor curatively treated with no known active disease
present and no treatment administered for = 5 years before randomization
• Prior chemotherapy or systemic therapy for the treatment of metastatic colorectal
carcinoma with the following exceptions:
o Subject may have received adjuvant fluoropyrimidine-based chemotherapy if
disease progression is documented at least 6 months after completion of
chemotherapy
o Subjects may have received prior fluoropyrimidine therapy if administered solely
for the purpose of radiosensitization
• Prior oxaliplatin therapy
• Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment with small molecule EGFr
inhibitors (eg, erlotinib)
• Any investigational agent or therapy = 30 days prior to randomization
• Radiotherapy = 14 days prior to randomization. Subjects must have recovered from all
radiotherapy related toxicities
• Known allergy or hypersensitivity to platinum-containing medications, 5-FU or leucovorin
• Active infection requiring systemic treatment or any uncontrolled infection = 14 days prior
to randomization
• Clinically significant cardiovascular disease (including myocardial infarction, unstable
angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) =
1 year prior to randomization
• History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of
interstitial lung disease on baseline chest CT scan
• Active inflammatory bowel disease or other bowel disease causing chronic diarrhea
(defined as > CTC grade 2 [CTCAE version 3.0])
• Known positive tests for human immunodeficiency virus (HIV) infection, hepatitis C virus,
acute or chronic active hepatitis B infection
• Any co-morbid disease or condition that could increase the risk of toxicity, eg,
dihydropyrimidine deficiency, significant ascites or pleural effusion
• Peripheral sensory neuropathy with functional impairment (> CTC grade 3 [CTCAE
version 3.0] neuropathy, regardless of causality)
• Any uncontrolled concurrent illness or history of any medical condition that may interfere
with the interpretation of the study results
• Major surgical procedure (requiring general anesthesia) = 28 days or minor surgical
procedure (excluding central venous catheter placement) = 14 days prior to
randomization. Subjects must have recovered from surgery related toxicities.
• Subject who is pregnant or breast feeding
• Woman or man of child-bearing potential not consenting to use adequate contraceptive
precautions ie. double barrier contraceptive methods (eg, diaphragm plus condom), or abstinence during the course of the study and for 6 months after the last study drug
administration for women, and 1 month for men
• Subject unwilling or unable to comply with study requirements
• Previously randomized into this study protocol


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with Previously Untreated Metastatic Colorectal Cancer

Intervention(s)

Product Name: Panitumumab
Product Code: AMG954
Pharmaceutical Form: Solution for infusion
Current Sponsor code: AMG954
Other descriptive name: Panitumumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Main Objective: To assess whether panitumumab in combination with infusional 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) chemotherapy improves progression-free survival (PFS) compared to FOLFOX alone as first-line therapy for metastatic colorectal cancer (mCRC).

Secondary Objective: To evaluate overall survival (OS), objective response rate (ORR), duration of response (DOR), time to progression (TTP), and safety and tolerability

Primary end point(s): Progression-free survival (PFS)

Secondary ID(s)

20050203

2006-000170-70-CZ