Recurrent Salivary Gland Cancer Clinical Trial
Official title:
A Phase 2 Study of GW572016 in Recurrent and/or Metastatic Adenoid Cystic Carcinoma, and Other EGFR-and/or erbB2-expressing Malignant Tumors of the Salivary Glands
Phase II trial to study the effectiveness of lapatinib in treating patients who have recurrent and/or metastatic adenoid cystic cancer or other salivary gland cancers. Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PRIMARY OBJECTIVES:
I. To determine the antitumor activity of GW572016 in recurrent and/or metastatic adenoid
cystic carcinoma of the salivary glands using objective response rates (partial and complete
responses).
SECONDARY OBJECTIVES:
I. To determine the duration of objective response, rate and duration of stable disease,
progression-free, median and overall survival rates of GW572016 in recurrent and/or
metastatic adenoid cystic carcinoma of the salivary glands.
II. To estimate the antitumor activity of GW572016 in other epidermal growth factor receptor
(EGFR)- and/or erbB2-overexpressing malignant tumors of the salivary glands using objective
response rates (partial and complete responses).
III. To document the safety and tolerability of GW572016 in these patient populations
TERTIARY OBJECTIVES:
I. To investigate if differences in baseline levels of EGFR and/or erbB2 expression, and
receptor phosphorylation status in tumor specimens predict outcome to therapy.
II. To investigate if the inhibitory effects of GW572016 on EGFR and/or erbB2 pathway
activation in tumor specimens correlate with clinical outcome.
III. To determine the steady state levels of GW572016 achieved, and their correlation with
clinical and laboratory correlative endpoints.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the
absence of unacceptable toxicity or disease progression.
Patients are followed for survival
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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