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
- Conditions
- Patients with Previously Untreated Metastatic Colorectal Cancer
- Registration Number
- EUCTR2006-000170-70-LV
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 900
• 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
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method