Study of Albumin Bound-Paclitaxel for Treatment of Recurrent or Metastatic Head and Neck Cancer With Cetuximab
Status:
Terminated
Trial end date:
2010-06-01
Target enrollment:
Participant gender:
Summary
Primary Objective: To assess the overall response rate (complete and partial response) to
Abraxane in patients with recurrent or metastatic head and neck cancer with the addition of
Cetuximab on disease progression.
Approximately 40,000 new cases of head and neck cancer are diagnosed annually in the United
States (Jemal et al, 2003), and over 30% of these patients are expected to die of their
malignancy. Squamous cell carcinoma accounts for more than 90% of head and neck cancer cases.
Although metastatic disease at the time of diagnosis is rather uncommon, and despite
aggressive use of up-front concurrent radiation and cisplatin-based chemotherapy,
approximately 20% of the patients will develop metastases. Patients with recurrent or
metastatic squamous cell carcinoma of the head and neck (SCCHN) have a poor prognosis
A subsequent randomized study conducted by ECOG (E1393) compared high-dose paclitaxel (200
mg/m2) as a 24-hour infusion plus cisplatin 75 mg/m2 with G-CSF support, to low dose
paclitaxel (135 mg/m2) as a 24-hour infusion, plus cisplatin 75 mg/m2 (Forastiere et al,
2001). Patients with newly diagnosed metastatic or recurrent squamous cell carcinoma of the
head and neck, excluding nasopharyngeal primaries were eligible. No prior treatment for
recurrent/metastatic disease was allowed, but patients could have received chemotherapy as a
part of the initial curative therapy that should have been completed 6 months prior to study.
No statistically significant difference could be demonstrated either in response rates or
survival between the two arms (Murphy et al, 2001). This study, however, indicated that
paclitaxel, a member of the taxane class of anti-tumor agent, is active in head and neck
cancer.
New agents to treat head and neck cancer need to be investigated. Abraxane, an albumin-bound
formulation of paclitaxel has shown significant single-agent activity in breast cancer and in
head and neck cancer. Recently, Abraxane has approved for use in metastatic breast cancer.
Given previous randomized phase III trials indicated single agent chemotherapy fared as well
as combination chemotherapy regimen in terms of overall survival, this novel formulation
should be actively investigated in head and neck cancer.