PACCE: Panitumumab Advanced Colorectal Cancer Evaluation Study

Sponsor
Amgen
Study ID
NCT00115765
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oxaliplatin Based Chemotherapy — DRUG
    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.
  • Panitumumab — DRUG
    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 — DRUG
    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 — DRUG
    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 .

Study Details

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.

Key Dates

Start date
Jun 1, 2005
Status verified
Sep 2018
Primary completion
May 31, 2007
Completion
May 1, 2009

Study Design

Enrollment
1,053 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Oxaliplatin and bevacizumab without panitumumab
    Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone.
  • Experimental: Irinotecan and bevacizumab plus panitumumab
    Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W
  • Active Comparator: Irinotecan and bevacizumab without panitumumab
    Irinotecan-based chemotherapy and Bevacizumab Q2W alone
  • Experimental: Oxaliplatin and bevacizumab plus panitumumab
    Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W

Primary Outcome Measure

Progression-Free Survival (Oxaliplatin) [ Time Frame: Overall study ]

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