NCT00095563

Lapatinib in Treating Patients With Recurrent and/or Metastatic Adenoid Cystic Cancer or Other Salivary Gland Cancers

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• High-grade Salivary Gland Carcinoma
• High-grade Salivary Gland Mucoepidermoid Carcinoma
• Low-grade Salivary Gland Carcinoma
• Low-grade Salivary Gland Mucoepidermoid Carcinoma
• Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
• Recurrent Salivary Gland Cancer
• Salivary Gland Acinic Cell Tumor
• Salivary Gland Adenocarcinoma
• Salivary Gland Adenoid Cystic Carcinoma
• Salivary Gland Malignant Mixed Cell Type Tumor

Interventions

Type	Name	Description
DRUG	lapatinib ditosylate	Given orally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2004-09-01
• Primary completion: 2009-02-01
• Completion: 2009-06-01
• First posted: 2004-11-08
• Last updated: 2017-04-18
• Results posted: 2017-04-18

Locations

1 site across 1 country: Canada