Lapatinib (GW572016) for Metastatic or Recurrent Squamous Cell Carcinoma Esophagus - Full Text View

Sponsored by:	University of Michigan Cancer Center
Information provided by:	University of Michigan Cancer Center
ClinicalTrials.gov Identifier:	NCT00239200

Purpose

The purpose of this study is the determine whether a new compound, called lapatinib, can be effective in shrinking cancerous tumors of the esophagus that have recurred or spread somewhere else in the body. They also want to determine the toxicity of this regimen. Lapatinib blocks 2 receptors that sometimes are present on cancer cells (called epidermal growth factor receptor, and the Erb B2 receptor). It is possible that blocking these receptors may decrease the growth of the cancer cells.

Condition	Intervention	Phase
Metastatic or Recurrent Squamous Cell Carcinoma of the Esophagus	Drug: Lapatinib	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Lapatinib (GW572016) a Dual Inhibitor of EGFR and ErbB2, for Metastatic or Recurrent Squamous Cell Carcinoma of the Esophagus

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer

Drug Information available for: Lapatinib Lapatinib Ditosylate

U.S. FDA Resources

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:

Primary Outcome:
Primary Objective: To determine the response rate of metastatic or recurrent squamous cell carcinoma of the esophagus, when treated with lapatinib (GW572016)

Secondary Outcome Measures:

Secondary Outcome:
Secondary Objective: To determine the toxicity of this regimen

Estimated Enrollment:	29
Study Start Date:	October 2005
Study Completion Date:	September 2007
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Detailed Description:

The subject will take an oral pill called Lapatinib. Each tablet is 250 mg. Subjects will take 1500mg (six 250mg tablets) of lapatinib once daily. Subjects must fast 1 hour prior to and 1 hour following dosing. If a subject is unable to swallow lapatinib tablets whole, the lapatinib may be crushed with a mortar and pestle to form a powder, and mix it in 4 oz (120 ml) of water to take by mouth or through a feeding tube. Then the subject will then rinse the mortar with 2 oz (60ml) of water to suspend the left-over powder, and then swallow the rinse or flush it down the feeding tube. You will have to repeat this rinse one more time.

Subjects will have a "MUGA" scan done at the very beginning to make sure that heart function is good.

It will then be repeated every other month while on treatment. When the subjects have a MUGA scan, 3 cc's (less than one teaspoon) of blood will be drawn from your vein, and labeled with a radioactive substance. Then, subjects blood will be injected back into his/her arm through a catheter in your vein. The level of radiation you will be exposed to is very minimal. Then, a camera will take a "movie" of your heart. The entire procedure lasts about 90 minutes.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have metastatic or recurrent squamous cell carcinoma of the esophagus.
Patients must have histologically or cytologically confirmed disease.
Patients may have received one prior regimen of neoadjuvant chemotherapy or chemoradiation, and prior esophagectomy is acceptable. Patients may also have received one prior chemotherapy regimen for recurrent disease.
Patients may have received no more than 4500 cGy to fields including substantial marrow.
Age greater than or equal than 18 years. Because no dosing or adverse event data are currently available on the use of GW572016 in patients <18 years of age, children are excluded from this study.
Life expectancy of greater than 12 weeks.
Patients must have normal organ and marrow function as defined below:

Leukocytes greater than or equal to 3,000/microliters Absolute neutrophil count greater than or equal to 1,500/microliters Platelets greater than or equal to 100,000/microliters Total bilirubin within normal institutional limits AST(SGOT)/ALT(SGPT)less than or equal to 2.5 X institutional upper limit of normal Creatine within normal institutional limits OR creatinine clearance greater than or equal to 60 ml/min for patients with creatinine levels above institutional normal

Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan.

A normal ejection fraction is equal or greater than 50%. Baseline and on treatment scans should be performed using the same modality and preferably at the same institution.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239200

Locations

United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan Cancer Center

More Information

No publications provided

Study ID Numbers:	UMCC 2005-037
Study First Received:	October 12, 2005
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00239200 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Esophageal Neoplasms
Lapatinib
Esophageal Cancer
Squamous Cell Carcinoma
Protein Kinase Inhibitors
Recurrence
Carcinoma

Digestive System Diseases
Esophageal Disorder
Head and Neck Neoplasms
Epidermoid Carcinoma
Gastrointestinal Neoplasms
Esophageal Diseases
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Disease Attributes
Neoplasms by Histologic Type
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Esophageal Neoplasms
Enzyme Inhibitors
Lapatinib
Protein Kinase Inhibitors
Pharmacologic Actions
Recurrence

Carcinoma
Neoplasms
Pathologic Processes
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009