CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
capecitabine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00891878
NCT00891878Phase 2Completed

A Randomized Phase II Trial of Sunitinib Plus Capecitabine Versus Capecitabine Alone (With the Potential for Crossover) for Elderly and/or Poor Performance Status Patients With Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction

Alliance for Clinical Trials in Oncology·interventional·Posted May 1, 2009·Updated Jul 24, 2018

In Brief

A Phase 2 clinical trial evaluating capecitabine and sunitinib malate for Adenocarcinoma of the Gastroesophageal Junction and Esophageal Cancer. Completed, enrolled 12 participants across 182 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 1, 2009
Enrollment StartAug 1, 2009
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 17.2 years ago

Interventions

capecitabinedrug

Given orally

sunitinib malatedrug

Given orally