Comparison of Survival Benefit of Panitumumab With Supportive Care to Best Supportive Care Alone in Patients With Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Best Supportive Care (BSC); Panitumumab
Intervention description: BSC was defined as the best palliative care available as judged appropriate by the investigator and according to institutional guidelines and could include antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any other symptomatic therapy as clinically indicated.; Administered intravenously
Intervention MeSH terms: Panitumumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 377.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Best Supportive Care; Panitumumab; Chemorefractory; Wild-type KRAS; Overall Survival; Phase 3

Summary:

      The purpose of this study is to evaluate the benefit of panitumumab in addition to best
      supportive care compared to best supportive care alone in patients with chemorefractory
      wild-type KRAS (Kirsten rat sarcoma viral oncogene homolog) metastatic colorectal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of metastatic colorectal cancer (CRC)

          -  Wild-type (without mutation in codons 12 and 13) KRAS gene in tumor tissue confirmed
             by a central laboratory

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

          -  At least 1 measurable or non-measurable lesion per Response Evaluation Criteria in
             Solid Tumors (RECIST) version 1.1 guidelines.

          -  Treatment failure (defined as failure due to either disease progression [clinical or
             radiological] or toxicity [treatment intolerance]) of a prior regimen containing
             irinotecan for metastatic disease and a prior regimen containing oxaliplatin for
             metastatic disease. Oxaliplatin and irinotecan may have been administered sequentially
             or in combination.

               -  Disease relapse within 6 months after completing adjuvant chemotherapy (with
                  either an irinotecan or oxaliplatin containing regimen) will also be considered
                  as treatment failure of a prior regimen for metastatic disease

          -  Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil,
             capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of CRC

          -  Man or woman at least 18 years of age

          -  Adequate hematologic, renal, hepatic and metabolic function

          -  Negative pregnancy test within 72 hours before randomization (for women of
             childbearing potential only)

          -  Subject or subject's legally acceptable representative has provided informed consent.

          -  Other protocol-specified criteria may apply

        Exclusion Criteria:

          -  Symptomatic brain metastases requiring treatment

          -  History of another primary cancer within 5 years of randomization

          -  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) within 21 days before randomization

          -  Radiotherapy within 14 days before randomization.

          -  Exclusion Criteria for corrected QT (QTc) Evaluation Subpart of the Study:
             Prolongation of QT/QTc interval > 450 milliseconds at screening

          -  Other protocol-specified criteria may apply