At a glance
ClinicalIndex Comparison Record- ✓Adenocarcinoma of the colon or rectum with metastatic disease
- ✓Measurable disease per modified RECIST criteria
- ✓ECOG performance status 0 or 1
- ✓Available paraffin-embedded tumor tissue from primary tumor or metastasis
- ✕Prior chemotherapy or biologic therapy for metastatic CRC
- ✕Adjuvant or radiosensitizing chemotherapy within 6 months of randomization
- ✕Radiotherapy within 14 days before randomization
- ✕Planned major surgery during trial course
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
PACCE: A Randomized, Open-Label, Controlled, Clinical Trial of Chemotherapy and Bevacizumab With and Without Panitumumab in the First-Line Treatment of Subjects With Metastatic Colorectal Cancer
In Brief
A Phase 3 clinical trial evaluating Oxaliplatin Based Chemotherapy, Panitumumab, and 2 other interventions for Colorectal Cancer. Completed, enrolled 1,053 participants.
Detailed Summary
The purpose of this study is to assess whether treatment with the study drug, panitumumab given concomitantly with every 2 (Q2) week oxaliplatin-based chemotherapy and bevacizumab improves progression-free survival (PFS) compared to treatment Q2-week with oxaliplatin-based chemotherapy and bevacizumab alone. All subjects will receive Q2-week oxaliplatin- or irinotecan-based chemotherapy and bevacizumab. Control arm subjects will not receive concomitant panitumumab therapy.
Study Details
Timeline
Interventions
Oxaliplatin-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) consisting of Oxaliplatin, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration.
PanitumumabPanitumumab is a high affinity (Kd = 5 x 10-11 M) fully human IgG2 monoclonal antibody that is directed against the human EGFr. Panitumumab will be administered by a 30-60 minute IV infusion at a dose of 6 mg/kg once every 2 weeks on the same day of the oxaliplatin- or irinotecan-based chemotherapy and bevacizumab.
Irinotecan-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) - Irinotecan, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration.
Bevacizumab is a vascular endothelial growth factor (VEGF)-targeted antibody therapy that was administered to subjects intravenously Q2 weeks as per usual standard of care on the same day of chemotherapy and panitumumab administration .