Weekly Oxaliplatin and Gemcitabine for Recurrent or Metastatic Head and Neck Cancer
Status:
Terminated
Trial end date:
2011-10-01
Target enrollment:
Participant gender:
Summary
The combination of oxaliplatin and gemcitabine is highly active in a wide variety of tumors
including pancreatic, germ cell, breast, biliary, mesothelioma (Mitchell et al, 2002), and
lung. In the last study which utilized days 1 and 8 gemcitabine 1000 mg/m2 and days 1 and 8
oxaliplatin 65 mg/m2 in poor prognosis lung cancer patients (PS 1-3) the response rate was
16% with no incidence of febrile neutropenia.
Toxicity is a crucial consideration when designing regimens intended for palliation.
Toxicities associated with cisplatin can make it difficult to use in patients with Head and
Neck Cancer (HNC), many of whom are elderly and have comorbidities. In addition, many
patients with metastatic HNC have previously received cisplatin during neoadjuvant/adjuvant
therapy, or as part of their primary chemoradiation treatment. When these patients recur, it
is possible their tumors have innate or acquired cisplatin resistance. Oxaliplatin is likely
to be better tolerated than cisplatin containing regimens, especially with regards to
neurotoxicity. Gemcitabine has shown promising activity as a single agent and in combination
chemotherapy in the first line treatment of patients with HNC. A combination chemotherapy
regimen using oxaliplatin and gemcitabine administered once every week is logical and worth
exploring in patients with metastatic and recurrent head and neck cancer to improve the
toxicity profile and patient monitoring while maintaining efficacy of the chemotherapy
regimen.
Phase:
Phase 2
Details
Lead Sponsor:
Sai-Hong Ignatius Ou University of California, Irvine