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A Randomized, Multicenter, Open-label, Phase 3 Study to Compare the Efficacy and Safety of Panitumumab and Cetuximab in Subjects With Previously Treated, Wild-type KRAS, Metastatic Colorectal Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Metastatic Colorectal Cancer

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Trial Information

A Randomized, Multicenter, Open-label, Phase 3 Study to Compare the Efficacy and Safety of Panitumumab and Cetuximab in Subjects With Previously Treated, Wild-type KRAS, Metastatic Colorectal Cancer


Inclusion Criteria:



- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or
rectum, metastatic disease

- Wild-type KRAS tumor status

- Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2

- Must have failed a prior regimen containing irinotecan for metastatic disease and a
prior regimen containing oxaliplatin for metastatic disease

- Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil,
capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of
colorectal cancer (CRC)

- Adequate hematologic, renal, hepatic and metabolic function

Exclusion Criteria:

- Symptomatic brain metastases requiring treatment

- Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, panitumumab
or cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib,
erlotinib, lapatinib)

- Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody
therapy, radiotherapy), or investigational agent or therapy ≤ 30 days before
randomization.

- Clinically significant cardiovascular disease

- Active infection requiring systemic treatment or any uncontrolled infection ≤14 days
prior to randomization

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare the effect of panitumumab versus cetuximab on overall survival for chemorefractory mCRC among subjects with wild-type KRAS tumors.

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Quorom Institutional Review Board

Study ID:

20080763

NCT ID:

NCT01001377

Start Date:

February 2010

Completion Date:

September 2014

Related Keywords:

  • Metastatic Colorectal Cancer
  • Panitumumab
  • Vectibix
  • Colon Cancer
  • Colorectal Cancer
  • Rectal Cancer
  • Cetuximab
  • Erbitux
  • Metastatic
  • Colorectal Neoplasms

Name

Location

Research SiteAnaheim, California  
Research SiteBoca Raton, Florida  
Research SiteHays, Kansas  
Research SiteAbilene, Texas  
Research SiteIvins, Utah