drugset / Trial / NCT00115765
PACCE: Panitumumab Advanced Colorectal Cancer Evaluation Study
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2005-06-01
- Primary completion
- 2007-05-31
- Completion
- 2009-05-01
Outcome
Missed primary endpoint
registry p = 0.011; Hazard Ratio (HR) 1.27 (95% CI 1.06 to 1.52) NCT00115765 ↗
registry p = 0.738; Odds Ratio (OR) 1.11 (95% CI 0.60 to 2.05) NCT00115765 ↗
Publications
- Background Hecht JR, Mitchell E, Chidiac T, Scroggin C, Hagenstad C, Spigel D, Marshall J, Cohn A, McCollum D, Stella P, Deeter R, Shahin S, Amado RG. A randomized phase IIIB trial of chemotherapy, bevacizumab, and panitumumab compared with chemotherapy and bevacizumab alone for metastatic colorectal cancer. J Clin Oncol. 2009 Feb 10;27(5):672-80. doi: 10.1200/JCO.2008.19.8135. Epub 2008 Dec 29.
- Abdel-Rahman O. Effect of Body Mass Index on 5-FU-Based Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer; A Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Dec;18(4):e385-e393. doi: 10.1016/j.clcc.2019.07.005. Epub 2019 Jul 15.
- Abdel-Rahman O. Impact of Sex on Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer: Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Jun;18(2):110-115.e2. doi: 10.1016/j.clcc.2018.12.006. Epub 2018 Dec 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Panitumumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Background | Bevacizumab | Monoclonal antibody | — | Intravenous |
| Background | Irinotecan | Small molecule | — | — |
| Background | Leucovorin | Small molecule | — | — |
| Background | Oxaliplatin | Small molecule | — | — |
| Background | fluorouracil | Small molecule | — | — |