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

NCT00239200 | Terminated Phase 2

• 1 other identifier: UMCC 2005-037
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic or Recurrent Squamous Cell Carcinoma of the Esophagus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Secondary Outcome:

• Secondary Objective: To determine the toxicity of this regimen

Interventions

Lapatinib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Esophageal Squamous Cell Carcinoma

Interventions

Lapatinib

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 12, 2005
• First Posted: October 14, 2005
• Study Start: October 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: September 1, 2007
• Last Updated: July 30, 2008

Record last verified: 2008-07

Locations

US (1)