NCT00098631

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Last Updated

January 7, 2014

Status Verified

January 1, 2014

Enrollment Period

2.2 years

First QC Date

December 7, 2004

Last Update Submit

January 6, 2014

Conditions

Metastatic Squamous Neck Cancer With Occult PrimaryRecurrent Metastatic Squamous Neck Cancer With Occult PrimaryRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavitySalivary Gland Squamous Cell CarcinomaStage IV Squamous Cell Carcinoma of the HypopharynxStage IV Squamous Cell Carcinoma of the LarynxStage IV Squamous Cell Carcinoma of the Lip and Oral CavityStage IV Squamous Cell Carcinoma of the NasopharynxStage IV Squamous Cell Carcinoma of the OropharynxStage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityUntreated Metastatic Squamous Neck Cancer With Occult Primary

Outcome Measures

Primary Outcomes (2)

  • Objective response rate by RECIST

    The 95% confidence intervals should be provided.

    Up to 6 years

  • Progression-free survival (PFS)

    Will be estimated using the Kaplan-Meier method.

    From start of treatment to time of disease progression, assessed up to 6 years

Secondary Outcomes (3)

  • Overall survival

    Up to 6 years

  • Changes in EGFR, pEGFR, HER2

    Baseline and 12 weeks

  • Adverse events assessed using NCI CTCAE version 3.0

    Up to 6 years

Study Arms (1)

Treatment (lapatinib ditosylate)

EXPERIMENTAL

Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: lapatinib ditosylateOther: laboratory biomarker analysis

Interventions

lapatinib ditosylateDRUG

Given orally

Treatment (lapatinib ditosylate)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (lapatinib ditosylate)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
  • Recurrent and/or metastatic disease
  • Measurable disease
  • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • No more than 2 prior treatment regimens for recurrent or metastatic disease
  • Prior chemotherapy as part of initial curative intent therapy (e.g., neoadjuvant, adjuvant, or concurrent chemotherapy) is allowed and does not count as prior therapy for recurrent or metastatic disease
  • No known brain metastases
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • More than 3 months
  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Creatinine normal
  • Creatinine clearance \> 60 mL/min
  • Cardiac ejection fraction normal by echocardiogram or MUGA
  • +27 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Lapatinib

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ezra Cohen

    University of Chicago Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2004

First Posted

December 8, 2004

Study Start

October 1, 2004

Primary Completion

December 1, 2006

Last Updated

January 7, 2014

Record last verified: 2014-01

Locations

US(1)