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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 Study of Oblimersen, Oxaliplatin, Fluorouracil, and Leucovorin Calcium in Patients With Advanced Colorectal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 18 and over NCI SACI-IDD-02-23 NCI-5793, NCT00055822, 5793

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Oblimersen may increase the effectiveness of chemotherapy by making tumor cells more sensitive to the drugs.

Phase I/II trial to study the effectiveness of combining oxaliplatin, fluorouracil, and leucovorin with oblimersen in treating patients who have unresectable, metastatic, or recurrent colorectal cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable or evaluable disease
• No previous oblimersen or oxaliplatin
• At least 4 weeks since chemotherapy or radiation therapy
• 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 5-day continuous infusion of oblimersen in weeks 1 and 3. They will receive a 2-hour infusion of leucovorin and a 22-hour infusion of fluorouracil on days 6, 7, 20, and 21. Patients will also receive a 2-hour infusion of oxaliplatin on days 6 and 20. Treatment may be repeated every 4 weeks for as long as benefit is shown. Patients will be evaluated at 1 month.

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

San Antonio Cancer Institute

Anthony Tolcher, MD, Protocol chair		Ph: 210-616-5914

Registry Information
Official Title		A Phase I/II Study of Oblimersen Sodium (G3139, Genasense) in Combination with Oxaliplatin, 5FU and Leucovorin (FOLFOX4) Regimen in Advanced Colorectal Cancer
Trial Start Date		2002-10-25
Registered in ClinicalTrials.gov		NCT00055822
Date Submitted to PDQ		2003-01-17
Information Last Verified		2005-03-01
NCI Grant/Contract Number		U01-CA69853

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