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

Alternate Title

Phase I/II Pilot Study of Oblimersen, Cisplatin, and Fluorouracil in Patients With Advanced Esophageal, Gastroesophageal Junction, or Gastric Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	Over 18	NCI	AECM-0266 NCI-5835, AECM-0302032, NCT00064259, 5835

Trial Description

Purpose:

Drugs used in chemotherapy such as cisplatin and fluorouracil use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of chemotherapy by making tumor cells more sensitive to the drugs.

This phase I/II trial is studying the side effects and best dose of oblimersen when given with cisplatin and fluorouracil and to see how well they work in treating patients with locally advanced, recurrent, or metastatic cancer of the esophagus, gastroesophageal junction, or stomach.

Eligibility:

Eligibility criteria include the following:

• At least 19 years old
• Measurable or evaluable disease
• No brain metastases
• At least 3 weeks since chemotherapy or radiation therapy
• More than 4 weeks since photodynamic therapy
• No previous oblimersen
• 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 receive a 7-day continuous infusion of oblimersen. They will also receive a 5-day continuous infusion of fluorouracil beginning on day 4, and an infusion of cisplatin on day 4. Treatment may be repeated every 3 weeks for as long as benefit is shown.

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

Albert Einstein Cancer Center at Albert Einstein College of Medicine

Andreas Kaubisch, MD, Protocol chair		Ph: 718-920-4826

Registry Information
Official Title		A Phase I/II Study of Genasense (G3139) in Combination with Cisplatin and Fluorouracil in Patients with Advanced Esophageal, Gastro-Esophageal Junction and Gastric Cancer
Trial Start Date		2003-06-18
Registered in ClinicalTrials.gov		NCT00064259
Date Submitted to PDQ		2003-05-27
Information Last Verified		2006-11-10
NCI Grant/Contract Number		CM62204

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