Phase 2
Completed N=203
Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer
Source: ClinicalTrials.gov NCT00089635 ↗Enrolled (actual)
203
Serious AEs
30.0%
Results posted
Dec 2013
Primary outcomePrimary: Objective Tumor Response Through Week 16 — 6 participants
Summary
The purpose of this study is to determine that panitumumab will have clinically meaningful anti-tumor activity in patients with metastatic colorectal cancer who have developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Tumor Response Through Week 16 |
6 | — |
| PRIMARY Duration of Response |
22.2 | — |
| SECONDARY Objective Tumor Response Throughout the Study |
7 | — |
| SECONDARY Time to Initial Objective Response |
11 | — |
| SECONDARY Progression-free Survival Time |
8.1 | — |
| SECONDARY Time to Disease Progression |
8.3 | — |
| SECONDARY Time to Treatment Failure |
8.4 | — |
| SECONDARY Duration of Stable Disease |
16.0 | — |
| SECONDARY Overall Survival |
9.0 | — |
Eligibility Criteria
Inclusion Criteria
- Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy)
- Metastatic colorectal carcinoma
- Eastern Cooperative Oncology Group of 0, 1 or 2
- Documented evidence of disease progression during, or following treatment, with fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal cancer
- Radiographic documentation of disease progression during or within 6 months following the most recent chemotherapy regimen is required
- Bidimensionally measurable disease
- Tumor expressing low to negative levels of epidermal growth factor receptor (EGFr) by immunohistochemistry
- At least 2 but no more than 3 prior chemotherapy regimens for metastatic colorectal cancer
- Adequate hematologic, renal and hepatic function
Exclusion Criteria
- Symptomatic brain metastases requiring treatment
- Patient with a history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis
- Use of systemic chemotherapy or radiotherapy within 30 days before enrollment
- Prior anti-EGFr antibody therapy with the exception of the small molecule EGFr tyrosine kinase inhibitors, which are permitted
- Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than 1 week) serum half-life within 30 days before enrollment, or prior experimental or approved proteins within 6 weeks before enrollment
Data sourced from ClinicalTrials.gov (NCT00089635). 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.