A Randomized, Multicenter, Phase 2 Study to Compare the Efficacy of Panitumumab in Combination With mFOLFOX6 to the Efficacy of Bevacizumab in Combination With mFOLFOX6 in Patients With Previously Untreated, KRAS Wild-Type, Unresectable, Metastatic Colorectal Cancer - 20070509
- Conditions
- Previously Untreated, KRAS Wild-Type, Unresectable, Metastatic Colorectal CancerMedDRA version: 9.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancer
- Registration Number
- EUCTR2008-004281-71-IT
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 280
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 disease
At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST
guidelines using conventional techniques (CT scan or MRI) or 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 confirmed by central laboratory assessment of paraffinembedded
tumor tissue from the primary tumor or metastasis
Adequate hematology, renal, hepatic, and coagulation function (see Section 4.1.3)
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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) 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 Radiotherapy ≤ 14 days prior to randomization. Subjects must have recovered from all
radiotherapy-related toxicities.
Significant cardiovascular risk (see Section 4.2.4)
Significant bleeding risk (see Section 4.2.4)
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
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to estimate the treatment effect on progression-free survival (PFS) of panitumumab relative to bevacizumab in combination with mFOLFOX6 chemotherapy as first-line therapy for mCRC in subjects with tumors expressing wild-type KRAS.;Secondary Objective: The secondary objectives are to evaluate overall survival (OS), objective response (OR), duration of response (DOR), time to progression (TTP), time to response, resectability, safety and tolerability of panitumumab relative to bevacizumab in combination with mFOLFOX6 chemotherapy as first-line therapy for mCRC in subjects with tumors expressing wild-type KRAS.;Primary end point(s): Progression-free survival (PFS
- Secondary Outcome Measures
Name Time Method