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Type(s) of Cancer
Colorectal
Study Phase
Phase 3
Study Completion Date
2007-05-31
NCT00115765Uploaded 08-03-2018
Available for Download
PDS UID: Colorec_Amgen_2005_262
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
Provider Information
Provider Data DescriptionPrimary Objective - To assess whether treatment with panitumumab given concomitantly with every 2 (Q2) week oxaliplatin-based chemotherapy and bevacizumab improves progression- free survival (PFS) compared to treatment with Q2-week oxaliplatin-based chemotherapy and bevacizumab alone. Secondary Objectives - To assess 1) Whether treatment with panitumumab given concomitantly with oxaliplatin-based chemotherapy and bevacizumab improves the following endpoints compared to treatment with oxaliplatin-based chemotherapy and bevicizumab alone: Overall Survival; Response rates (complete [CR] and partial [PR] responses [at week 12 and best overall response during 1st line treatment]); Time to progression (TTP); Time to treatment failure (TTF); Duration of response and Rate of stable disease (SD) and duration of SD. 2) The safety of panitumumab given concomitantly with oxaliplatin-based chemotherapy and bevicizumab as compared to treatment of oxaliplatin-based chemotherapy and bevicizumab alone and 3) The safety and efficacy of panitumumab given concomitantly with irinotecan-based chemotherapy and bevicizumab as compared to treatment of irinotecan-based chemotherapy and bevicizumab alone.
SponsorAmgen
Data ProviderAmgen
Partial set or SubsetOriginal Data
Patients in dataset1053
# of Patients Control525
# of Patients Experimental528
DOIhttps://doi.org/10.34949/a40v-5664
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryThe 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.
ConditionsColorectal Cancer
Intervention TypeDrug: Oxaliplatin Based Chemotherapy
Drug: Panitumumab
Drug: Irinotecan Based Chemotherapy
Drug: Bevacizumab
Drug(s)Drug: Oxaliplatin Based Chemotherapy
Drug: Bevacizumab
Drug: Panitumumab
Drug: Irinotecan Based Chemotherapy
Total Enrolled1053
RandomizationRandomized
Blinding MethodNone
Arms InterventionOxaliplatin and bevacizumab without panitumumab - Active Comparator
Irinotecan and bevacizumab plus panitumumab - Experimental
Irinotecan and bevacizumab without panitumumab - Active Comparator
Oxaliplatin and bevacizumab plus panitumumab - Experimental
Secondary IDN/A
PubMed (PMID)19114685
31378656
30679026
Collaborator(s)N/A
Region(s)N/A
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files:
PROTOCOL20040249_01.20.01 Protocol Amend 2 2007-08-07 English_Redacted.pdf
CRFAmgen 20040249 CRF REDACTED.pdf
DATA DICTIONARYAmgen 20040249 DDT.pdf
DATA (BOTH COMPARATOR AND ACTIVE ARMS)SAS dataset - 20040249.zip
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