Cancer Chemotherapy and Pharmacology

, Volume 73, Issue 4, pp 695–702

Figitumumab in patients with refractory metastatic colorectal cancer previously treated with standard therapies: a nonrandomized, open-label, phase II trial

  • Carlos R. Becerra
  • Ramon Salazar
  • Rocio Garcia-Carbonero
  • Anne L. Thomas
  • Federico J. Vázquez-Mazón
  • James Cassidy
  • Tim Maughan
  • Manuel Gallén Castillo
  • Tim Iveson
  • Donghua Yin
  • Stephanie Green
  • Emily K. Bergsland
Original Article

DOI: 10.1007/s00280-014-2391-2

Cite this article as:
Becerra, C.R., Salazar, R., Garcia-Carbonero, R. et al. Cancer Chemother Pharmacol (2014) 73: 695. doi:10.1007/s00280-014-2391-2

Abstract

Purpose

Figitumumab (CP-751,871) is a human IgG2 monoclonal antibody that binds and down-regulates insulin-like growth factor receptor-1 (IGF-1R) and inhibits activation of this receptor by IGF-1 and IGF-2. This nonrandomized, open-label, single-arm, phase II trial evaluated the antitumor activity and safety of figitumumab in patients with metastatic colorectal cancer that was refractory to ≥2 systemic therapies.

Methods

Cohorts A and B received intravenous figitumumab 20 and 30 mg/kg in 3-week cycles, respectively. Both received loading doses (20 or 30 mg/kg) on days 1 and 2 of cycle 1. The primary endpoint was 6-month survival (null hypothesis for each cohort, H0: p6 mo surv = 0.45). Secondary endpoints included progression-free survival (PFS), overall survival (OS), objective response, safety, and pharmacokinetics.

Results

A total of 168 patients (Cohort A, n = 85; Cohort B, n = 83) received figitumumab. Estimated 6-month survival was 49.4 % (95 % CI 38.8–60.0) in Cohort A and 44.1 % (95 % CI 33.4–54.9) in Cohort B. Median OS was 5.8 and 5.6 months, respectively; median PFS was 1.4 months in both cohorts. No objective partial or complete responses occurred. The respective rates of treatment discontinuation due to treatment-related adverse events (AEs) were 5 and 7 %. The most common grade 3/4 nonhematologic AEs in both cohorts were hyperglycemia and asthenia. No grade 4 hematologic laboratory abnormalities occurred. Most deaths were reported as due to progressive disease; none were due to figitumumab.

Conclusion

Six-month survival data do not support further study of figitumumab 20 or 30 mg/kg in this patient population.

Keywords

Figitumumab Phase II Metastatic colorectal cancer Safety 

Supplementary material

280_2014_2391_MOESM1_ESM.docx (14 kb)
Supplementary material 1 (DOCX 13 kb)

Copyright information

© Springer-Verlag Berlin Heidelberg 2014

Authors and Affiliations

  • Carlos R. Becerra
    • 1
    • 2
  • Ramon Salazar
    • 3
  • Rocio Garcia-Carbonero
    • 4
  • Anne L. Thomas
    • 5
  • Federico J. Vázquez-Mazón
    • 6
  • James Cassidy
    • 7
  • Tim Maughan
    • 8
  • Manuel Gallén Castillo
    • 9
  • Tim Iveson
    • 10
  • Donghua Yin
    • 11
  • Stephanie Green
    • 11
  • Emily K. Bergsland
    • 12
  1. 1.Texas Oncology-Sammons Cancer Center at BaylorDallasUSA
  2. 2.US OncologyThe WoodlandsUSA
  3. 3.Hospital Duran I ReynalsInstitut Catalá d’OncologiaBarcelonaSpain
  4. 4.Hospital Universitario Virgen del Rocío (HUVR), Instituto de Biomedicina de Sevilla (IBIS), CSICUniversidad de SevillaSevilleSpain
  5. 5.University of LeicesterLeicesterUK
  6. 6.Elche General University HospitalElcheSpain
  7. 7.The Beatson West of Scotland Cancer CentreGlasgowUK
  8. 8.University of OxfordOxfordUK
  9. 9.Hospital del MarBarcelonaSpain
  10. 10.University Hospitals Southampton NHS Foundation TrustSouthamptonUK
  11. 11.Pfizer IncGrotonUSA
  12. 12.University of California, San Francisco (UCSF)San FranciscoUSA

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