Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Randomized Study of Capecitabine With Versus Without Sunitinib Malate as First-Line Therapy in Elderly and/or Poor Performance Status Patients With Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction

Basic Trial Information

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable disease
• No CNS metastases
• No previous sunitinib malate
• More than 4 weeks since surgery
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive capecitabine by mouth twice a day for 2 weeks. Some patients may crossover to group two.

Patients in group two will receive capecitabine by mouth twice a day for 2 weeks. They will also receive sunitinib malate by mouth once a day in weeks 1-3.

In both groups, courses may repeat every 3 weeks for as long as benefit is shown.

Patients will undergo tumor tissue sample collection at the beginning of the study for laboratory studies.

After finishing treatment, patients will be evaluated periodically for 3 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Aminah Jatoi, MD, Protocol chair		Ph: 507-284-4918

Registry Information
Official Title		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
Trial Start Date		2009-08-14
Trial Completion Date		2010-11-01 (estimated)
Registered in ClinicalTrials.gov		NCT00891878
Date Submitted to PDQ		2009-04-17
Information Last Verified		2011-01-28
NCI Grant/Contract Number		CA25224

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