Clinical trial NCT00891878
Conditions: Adenocarcinoma of the Gastroesophageal Junction Esophageal Cancer
Keywords: adenocarcinoma of the esophagus adenocarcinoma of the gastroesophageal junction recurrent esophageal cancer stage IV esophageal cancer stage III esophageal cancer
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2009-08-01; Completion date: 2013-01-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether capecitabine is more effective when given alone or together with sunitinib malate in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer.

PURPOSE: This randomized phase II trial is studying how well capecitabine works compared with capecitabine given together with sunitinib malate as first-line therapy in treating patients with metastatic cancer of the esophagus or gastroesophageal junction.

Detailed description:
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.

Arms: arm 1: 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 2: Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
Interventions: intervention 1: capecitabine intervention 2: sunitinib malate
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally

Protocol documents: