Cisplatin With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether cisplatin plus monoclonal antibody therapy is more effective than cisplatin alone for metastatic or recurrent head and neck cancer. PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of cisplatin with or without monoclonal antibody in treating patients who have metastatic or recurrent head and neck cancer.

Timeline

Start

1999-08-06

Primary completion

2004-09

Completion

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Publications

• Results Burtness B, Goldwasser MA, Flood W, Mattar B, Forastiere AA; Eastern Cooperative Oncology Group. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study. J Clin Oncol. 2005 Dec 1;23(34):8646-54. doi: 10.1200/JCO.2005.02.4646.
• Results Burtness BA, Li Yi, Flood W, et al.: Phase III trial comparing cisplatin (C) + placebo (P) to C + anti-epidermal growth factor antibody (EGF-R) C225 in patients (pts) with metastatic/recurrent head & neck cancer (HNC). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-901, 2002.
• Chung CH, Lee JW, Slebos RJ, Howard JD, Perez J, Kang H, Fertig EJ, Considine M, Gilbert J, Murphy BA, Nallur S, Paranjape T, Jordan RC, Garcia J, Burtness B, Forastiere AA, Weidhaas JB. A 3'-UTR KRAS-variant is associated with cisplatin resistance in patients with recurrent and/or metastatic head and neck squamous cell carcinoma. Ann Oncol. 2014 Nov;25(11):2230-2236. doi: 10.1093/annonc/mdu367. Epub 2014 Jul 31.

Drugs

Indications