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

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00095563
Phase
PHASE2
Status
Completed

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • lapatinib ditosylate — DRUG
    Given orally
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

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.

Key Dates

Start date
Sep 30, 2004
Status verified
Mar 2017
Primary completion
Feb 28, 2009
Completion
Jun 30, 2009

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (lapatinib ditosylate)
    Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

Primary Outcome Measure

Objective Response Rates (Partial and Complete Responses) [ Time Frame: Up to 5 years ]

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