Phase I/II Pilot Study of Lapatinib in Combination With Carboplatin and Paclitaxel in the Treatment of Recurrent/Metastatic Adenocarcinoma of the Esophagus and Gastroesophageal Junction (GEJ)
1. Phase I: To assess the toxicity and feasibility of the addition of lapatinib to
carboplatin and paclitaxel in patients with recurrent/metastatic adenocarcinoma of the
esophagus and gastroesophageal junction.
2. Phase II: To assess the response rate to this regimen.
1. There will be an initial phase I safety cohort studies requiring up to 12 patients,
followed by a phase II cohort using the lapatinib dose defined in phase I. Carboplatin
and paclitaxel doses will not be escalated.
The initial dose of lapatinib of 750 mg daily by mouth will be given to 6 patients.
There will be no dose escalation of the lapatinib above 1000 mg daily. The lapatinib
dose for the phase II cohort of this trial will be based only on toxicities experienced
during the first cycle (3 weeks) of treatment.
2. Phase II: Once the optimal lapatinib dose has been chosen, all remaining patients will
initiate treatment at this dose level. Patients with stable or responding disease
after 6 cycles will continue treatment with lapatinib alone until progression of
disease or intolerable side effects. Feasibility, toxicity and response rate of this
combination will be assessed.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PHASE I:Number of patients that experience a grade 3-4 dose limiting toxicity
A dose limiting toxicity (DLT) will be defined as any grade 3-4 non-hematologic toxicity or increase in bilirubin >/= 2 mg/dL (>2X baseline in patients with Gilbert's syndrome), or elevation in AST/ALT > 3.0 X ULN during the first 3 week course of therapy.
after 9 weeks (3 cycles) of treatment
David Adelstein, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Institutional Review Board
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|