Phase 2
Completed N=185
Evaluating Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy
Source: ClinicalTrials.gov NCT00083616 ↗Enrolled (actual)
185
Serious AEs
34.1%
Results posted
Jul 2011
Primary outcomePrimary: Number of Participants With Objective Tumor Response Through Week 16 — 5 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 Number of Participants With Objective Tumor Response Through Week 16 |
5 | — |
| PRIMARY Duration of Response |
14.0 | — |
| SECONDARY Number of Participants With Objective Tumor Response Throughout Study |
5 | — |
| SECONDARY Time to Response |
11.0 | — |
| SECONDARY Progression-free Survival Time |
7.3 | — |
| SECONDARY Time to Disease Progression |
7.3 | — |
| SECONDARY Time to Treatment Failure |
8.0 | — |
| SECONDARY Duration of Stable Disease |
23.9 | — |
| SECONDARY Overall Survival |
7.0 | — |
Eligibility Criteria
Inclusion Criteria
- Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy)
- Metastatic colorectal carcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status 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 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 epidermal growth factor receptor targeting agents
- 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 with longer serum half-life (e.g., AvastinTM) within 6 weeks before enrollment
Data sourced from ClinicalTrials.gov (NCT00083616). 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.