A Phase 2 Study of Panitumumab Plus mFOLFOX6 vs. Bevacizumab Plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer Subjects With Wild-Type KRAS Tumors

Phase 1

• Conditions: Previously Untreated, KRAS Wild-Type, Unresectable, Metastatic Colorectal Cancer; MedDRA version: 17.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-004281-71-DE
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-19
• Last Update Posted: 23 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Key Inclusion Criteria

• Man or woman = 18 years of age at the time the informed consent is obtained
• ECOG performance status of 0 or 1
• Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum in
subjects with unresectable metastatic (M1) disease
• At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified
RECIST 1.0 guidelines using conventional techniques (CT scan or MRI) or at least 10 mm using spiral CT scan. Lesion must not be chosen from a previously irradiated
field, unless there has been documented disease progression in that field after irradiation and prior to randomization. All sites of disease must be evaluated = 28 days prior to randomization
• Wild-type KRAS tumor status of archival tumor tissue confirmed by an Amgen
approved central laboratory or an experienced laboratory (local laboratory) per
local regulatory guidelines using a validated test method
• Adequate hematology, renal, hepatic, and coagulation function
• Magnesium = lower limit of normal
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 168
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 112

Exclusion Criteria

Key Exclusion Criteria

• History of prior or concurrent central nervous system (CNS) metastases
• History of other malignancy, except:
• Malignancy treated with curative intent and with no known active disease present for = 3 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
• Prior chemotherapy or other systemic anticancer therapy for the treatment of metastatic colorectal carcinoma including but not limited to bevacizumab and anti-EGFr therapy (eg, cetuximab, panitumumab, erlotinib, gefitinib, lapatinib)
• Prior adjuvant chemotherapy (including oxaliplatin therapy) or other adjuvant systemic anticancer therapy including but not limited to bevacizumab and anti-EGFr therapy (eg, cetuximab, panitumumab, erlotinib, gefitinib, lapatinib) for the treatment of colorectal cancer = 52 weeks prior to randomization with the following exceptions:
• Subjects may have received prior fluoropyrimidine therapy if administered solely for
the purpose of radiosensitization for the adjuvant or neoadjuvant treatment of
rectal cancer
• Radiotherapy = 14 days prior to randomization. Subjects must have recovered from
all radiotherapy-related toxicities.
• Significant cardiovascular risk
• Significant bleeding risk
• History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline CT scan
• Active inflammatory bowel disease or other bowel disease causing chronic diarrhea
(defined as = CTC grade 2, [CTCAE version 3.0])
• Peripheral sensory neuropathy (= CTC grade 2 [CTCAE version 3.0]

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified