Phase 3
Completed N=1,183
PRIME: Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy
Source: ClinicalTrials.gov NCT00364013 ↗Enrolled (actual)
1,183
Serious AEs
39.4%
Results posted
Mar 2014
Primary outcomePrimary: Progression-free Survival — 9.6; 8.0; 7.3; 8.8 months — p=0.0234
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
9.6; 8.0; 7.3; 8.8 | 0.0234 sig |
| SECONDARY Overall Survival |
23.9; 19.7; 15.5; 19.3 | 0.0723 |
| SECONDARY Percentage of Participants With an Objective Response |
55.21; 47.68; 39.53; 40.28 | 0.0684 |
| SECONDARY Time to Progression |
10.8; 9.2; 7.5; 9.0 | — |
| SECONDARY Duration of Response |
11.1; 8.8; 7.4; 8.0 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
583; 579; 262; 198; 136; 84 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00364013). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.