Phase 2
N=285
PEAK: Panitumumab Plus mFOLFOX6 vs. Bevacizumab Plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer (mCRC) Patients With Wild-Type Kirsten Rat Sarcoma-2 Virus (KRAS) Tumors
Colon Cancer · Colorectal Cancer · Rectal Cancer · Metastatic Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00819780 ↗Enrolled (actual)
285
Serious AEs
41.0%
Results posted
Aug 2014
Primary outcome: Primary: Progression-free Survival (PFS) — 10.9; 10.1 months — p=0.3531
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Panitumumab (Drug); Bevacizumab (Drug); mFOLFOX6 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) |
10.9; 10.1 | 0.3531 |
| SECONDARY Overall Survival |
NA; 25.4 | 0.1386 |
| SECONDARY Percentage of Participants With an Objective Response |
57.75; 53.52 | 0.5497 |
| SECONDARY Duration of Response |
10.0; 9.0 | — |
| SECONDARY Time to Disease Progression |
11.0; 11.1 | 0.3861 |
| SECONDARY Time to Initial Objective Response |
1.8; 1.9 | — |
| SECONDARY Resection Rate |
12.68; 11.19 | — |
| SECONDARY Progression-free Survival (PFS) in Participants With Wild-type Rat Sarcoma Viral Oncogene Homolog (RAS) |
13.0; 9.5 | 0.0286 sig |
| SECONDARY Progression-free Survival (PFS) in Participants With Wild-type RAS / V-raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF) |
13.1; 9.7 | 0.0083 sig |
| SECONDARY Overall Survival in Participants With Wild-type RAS |
NA; 29.0 | 0.0934 |
| SECONDARY Overall Survival in Participants With Wild-type RAS / BRAF |
NA; 29.0 | 0.0235 sig |
| SECONDARY Percentage of Participants With an Objective Response for Participants With Wild-type RAS |
63.64; 60.49 | 0.9426 |
| SECONDARY Percentage of Participants With an Objective Response for Participants With Wild-type RAS / BRAF |
63.64; 61.54 | 1.0000 |
| SECONDARY Number of Participants With Adverse Events (AEs) |
139; 139; 88; 78; 31; 28 | — |
Summary
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 in patients with tumors expressing wild-type KRAS, unresectable mCRC.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum in patients with unresectable metastatic (M1) disease
- Patients with at least 1 uni-dimensionally measurable lesion of at least 10 mm per modified Response Evaluation Criteria in Solid Tumors (RECIST) guidelines
- Wild-type KRAS tumor status confirmed by an Amgen approved central laboratory or an experienced laboratory (local laboratory) per local regulatory guidelines using a validated test method
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Men or women 18 years of age or older
- Adequate hematologic, renal, hepatic, metabolic, and coagulation function
Exclusion Criteria
- History of prior or concurrent central nervous system (CNS) metastases
- Prior chemotherapy or other systemic anticancer therapy for treatment of metastatic colorectal carcinoma
- Clinically significant cardiac disease
- Clinically significant peripheral sensory neuropathy
- Active inflammatory bowel disease
- Recent gastroduodenal ulcer to be active or uncontrolled
- History of interstitial lung disease
- Recent pulmonary embolism, deep vein thrombosis, or other significant venous event
- Pre-existing bleeding diathesis and/or coagulopathy with exception of well-controlled anticoagulation therapy
- Recent major surgical procedure, open biopsy, or significant traumatic injury not yet recovered from prior major surgery.
Data sourced from ClinicalTrials.gov (NCT00819780). 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.