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

Amgen

Status and phase: Completed; Phase 3

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: FOLFOX regimen; Drug: Panitumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00364013

20050203

Details and patient eligibility

About

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 metastatic colorectal cancer

Enrollment: 1,183 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 20 mm per modified RECIST
• 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 analyse Exclusion Criteria:
• History or known presence of central nervous system (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-epidermal growth factor receptor (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 computed tomography (CT) scan
• Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as > Common terminology criteria (CTC) grade 2 [CTCAE version 3.0])
• Peripheral sensory neuropathy with functional impairment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,183 participants in 2 patient groups

FOLFOX + Panitumumab

Experimental group

Description:

Participants received panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.

Treatment:

Drug: FOLFOX regimen

Drug: Panitumumab

FOLFOX

Active Comparator group

Description:

Participants received FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.

Treatment:

Drug: FOLFOX regimen