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

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ClinicalTrials.gov Identifier: NCT00239200
Recruitment Status : Terminated (notification from sponsor)
First Posted : October 14, 2005
Last Update Posted : July 30, 2008
Sponsor:
Information provided by:
University of Michigan Cancer Center

October 12, 2005
October 14, 2005
July 30, 2008
October 2005
June 2006   (Final data collection date for primary outcome measure)
  • Primary Outcome:
  • Primary Objective: To determine the response rate of metastatic or recurrent squamous cell carcinoma of the esophagus, when treated with lapatinib (GW572016)
Same as current
Complete list of historical versions of study NCT00239200 on ClinicalTrials.gov Archive Site
  • Secondary Outcome:
  • Secondary Objective: To determine the toxicity of this regimen
Same as current
Not Provided
Not Provided
 
Lapatinib (GW572016) for Metastatic or Recurrent Squamous Cell Carcinoma Esophagus
Lapatinib (GW572016) a Dual Inhibitor of EGFR and ErbB2, for Metastatic or Recurrent Squamous Cell Carcinoma of the Esophagus
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic or Recurrent Squamous Cell Carcinoma of the Esophagus
Drug: Lapatinib
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
29
Same as current
September 2007
June 2006   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00239200
UMCC 2005-037
Not Provided
Not Provided
Not Provided
Not Provided
University of Michigan Cancer Center
Not Provided
Not Provided
University of Michigan Cancer Center
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP