Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Alliance for Clinical Trials in Oncology
With
OBJECTIVES: Primary * Compare the progression-free survival of elderly (age ≥ 65 years) and/or poor performance status patients with metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with capecitabine with verus without sunitinib malate. * Report other indicators of efficacy with these regimens, including the confirmed response rate, overall survival, time to tumor progression, duration of response, and time to treatment failure. * Compare the adverse event profiles of these regimens in these patients. Secondary * Explore whether certain key proteins associated with anti-VEGF therapy are able to predict tumor response. * Bank paraffin-embedded tissue blocks or slides, and blood products for future studies. OUTLINE: This is a multicenter study. Patients are stratified according to gender (male vs female), ECOG performance status (0 vs 1 vs 2), and age (≥ 65 years vs \< 65 years). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm II at the physician's discretion. * Arm II: Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21. In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Tumor tissue samples are collected at baseline for evaluation of protein markers as possible predictors of tumor response to this regimen. Samples are analyzed by IHC for expression levels of markers After completion of study therapy, patients are followed periodically for 3 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
