Adenocarcinoma of the Gastroesophageal Junction Clinical Trial
Official title:
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)
RATIONALE: Since lapatinib inhibits both EGFR and HER2 receptors, it is an attractive agent
for the treatment of esophageal and GEJ tumors.
PURPOSE: Lapatinib is currently approved for HER2 positive metastatic breast cancer in
combination with capecitabine or letrozole. It is hoped that by giving lapatinib and
carboplatin and paclitaxel together, their combined effects will further slow or stop the
cancer cells from growing.
OBJECTIVES:
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.
OUTLINE:
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.
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