Trials / Completed
CompletedNCT00098631
Lapatinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
A Phase II Study Of GW572016 In Squamous Cell Carcinoma Of The Head And Neck (SCCHN)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 88 (estimated)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. This phase II trial is studying how well lapatinib works in treating patients with recurrent and/or metastatic head and neck cancer.
Detailed description
PRIMARY OBJECTIVES: I. Determine the overall response rate in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with lapatinib. II. Determine the progression-free survival, time to progression, and overall survival of patients treated with this drug. III. Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 cohorts according to prior epidermal growth factor receptor-targeted therapy (yes vs no). Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 40-88 patients (21-50 epidermal growth factor receptor \[EGFR\] inhibitor-naive patients \[cohort A\] and 19-38 EGFR inhibitor-pre-treated patients \[cohort B\]) will be accrued for this study within 4-12.6 months.
Conditions
- Metastatic Squamous Neck Cancer With Occult Primary
- Recurrent Metastatic Squamous Neck Cancer With Occult Primary
- Recurrent Squamous Cell Carcinoma of the Hypopharynx
- Recurrent Squamous Cell Carcinoma of the Larynx
- Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
- Recurrent Squamous Cell Carcinoma of the Nasopharynx
- Recurrent Squamous Cell Carcinoma of the Oropharynx
- Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
- Salivary Gland Squamous Cell Carcinoma
- Stage IV Squamous Cell Carcinoma of the Hypopharynx
- Stage IV Squamous Cell Carcinoma of the Larynx
- Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage IV Squamous Cell Carcinoma of the Nasopharynx
- Stage IV Squamous Cell Carcinoma of the Oropharynx
- Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
- Untreated Metastatic Squamous Neck Cancer With Occult Primary
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | lapatinib ditosylate | Given orally |
| OTHER | laboratory biomarker analysis | Correlative studies |
Timeline
- Start date
- 2004-10-01
- Primary completion
- 2006-12-01
- First posted
- 2004-12-08
- Last updated
- 2014-01-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00098631. Inclusion in this directory is not an endorsement.