PRIME: Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy

The purpose of this study is to determine the treatment effect of panitumumab in combination with FOLFOX compared to FOLFOX alone as first line therapy for metatstatic colorectal cancer

Official 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

Conditions

Metastatic Colorectal Cancer

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

• Primary Outcome Measures: Progression Free Survival
• Secondary Outcome Measures: Overall survival (OS), objective response rate (ORR) duration of response (DOR), time to progression (TTP), and safety and tolerability

Study Start

July 2006; Expected completion: March 2010

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

• Man or woman at least 18 years old
• Diagnosis of metastatic colorectal cancer
• At least 1 uni-dimensionally measurable lesion of at least 20mm per modified RECIST
• ECOG performance status of 0, 1, or 2
• Paraffin-embedded tumor tisuue from the primary tumor or metastasis available for central analyse

Exclusion Criteria:

• History or known presence of CNS metastases
• History of another primary cancer, except: Curatively treated in situ cervical cancer, or Curatively resected non-melanoma skin cancer, or 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 except: adjuvant fluoropyrimidine-based chemotherapy or prior fluoropyrimidine therapy 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)
• 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])
• Peripheral sensory neuropathy with functional impairment

Total Enrolment

900

Contact Details

• Research Site, Prahran, Australia; Recruiting
• Research Site, Concord, New South Wales, Australia; Recruiting
• Research Site, Gosford, New South Wales, Australia; Recruiting
• More information here.