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 - ND
- Conditions
- 1st line metastatic colorectal cancer in combination with chemotherapyMedDRA version: 9.1Level: LLTClassification code 10052358Term: Colorectal cancer metastatic
- Registration Number
- EUCTR2006-000170-70-IT
- Lead Sponsor
- AMGEN S.P.A.
- 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 within 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 8805; 18 years of age Hematologic function, as follows within 7 days prior to randomization o Absolute neutrophil count ANC 8805; 1.5 x 109/L o Platelet count 8805; 100 x 109/L o Hemoglobin 8805; 9 g/dL Renal function, as follows within 7 days prior to randomization o Estimated creatinine clearance 8805; 50 ml/min Hepatic function, as follows within 7 days prior to randomization o Aspartate aminotransferase AST less or equal than 3 x ULN if liver metastases less or equal than 5 x ULN o Alanine aminotransferase ALT less or equal than 3 x ULN if liver metastases less or equal than 5 x ULN o Total bilirubin less or equal than 1.5 x ULN Metabolic function, as follows within 7 days prior to randomization o Magnesium more or equal than lower limit of normal Negative pregnancy test within 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 more or equal than 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 more or equal than 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 less or equal than 30 days prior to randomization Radiotherapy less or equal than 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 less or equal than 14 days prior to randomization Clinically significant cardiovascular disease including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia less or equal than 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 more or equal than 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 more or equal than 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 less or equal than 28 days or minor surgical procedure excluding central venous catheter placement less or equal than 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 Product Panitumumab Protocol Number 20050203 Date 09 March 2006 Page 6 of 123 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
- Secondary Outcome Measures
Name Time Method