Lapatinib (GW572016) for Metastatic or Recurrent Squamous Cell Carcinoma Esophagus

Metastatic or Recurrent Squamous Cell Carcinoma of the Esophagus Clinical Trial

Official title:

Lapatinib (GW572016) a Dual Inhibitor of EGFR and ErbB2, for Metastatic or Recurrent Squamous Cell Carcinoma of the Esophagus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00239200
• Other study ID #: UMCC 2005-037
• Status: Terminated
• Phase: Phase 2
• First received: October 12, 2005
• Last updated: July 28, 2008
• Start date: October 2005
• Est. completion date: September 2007

Study information

• Verified date: July 2008
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: September 2007
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Metastatic or Recurrent Squamous Cell Carcinoma of the Esophagus

Intervention

Drug:
• Lapatinib

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome:
Primary	Primary Objective: To determine the response rate of metastatic or recurrent squamous cell carcinoma of the esophagus, when treated with lapatinib (GW572016)
Secondary	Secondary Outcome:
Secondary	Secondary Objective: To determine the toxicity of this regimen