Relationship Between Platinum Levels in the Blood and Neurotoxicity in Patients Who Are Receiving Oxaliplatin for Gastrointestinal Cancer
Last Modified: 1/18/2008 First Published: 12/22/2005
Alternate Title
Basic Trial Information
Trial Description
Purpose
Eligibility
Treatment/Intervention
Trial Contact Information
Registry Information
Alternate Title
Phase IV Study of the Relationship Between Residual Platinum Levels in the Blood and Persistent Neurotoxicity in Patients Who Are Receiving Oxaliplatin for Gastrointestinal Cancer
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase IV | Supportive care, Treatment | Active | 18 and over | GERCOR-TAUROX
SANOFI-GERCOR-TAUROX, EU-20573, NCT00274885 |
Trial Description Purpose: Learning about the relationship between platinum levels in the blood and neurotoxicity in patients receiving oxaliplatin may help plan treatment and may help patients live more comfortably.
This phase IV trial is studying the relationship between platinum levels in the blood and neurotoxicity in patients who are receiving oxaliplatin for gastrointestinal cancer. Eligibility: Eligibility criteria include the following: - At least 18 years old
- Receiving or planning to receive a chemotherapy regimen that includes oxaliplatin for 8 months
- No signs of nerve damage, such as numbness or tingling, being sensitive to cold, or trouble breathing, swallowing, or talking
- No CNS cancer
- For more information about the eligibility criteria for this trial, refer to the Health Professional version. 5
Final eligibility for a clinical trial is determined by the health professionals conducting the trial. Treatment/Intervention: Patients will receive a 2-hour infusion of oxaliplatin. Treatment may repeat every 2-3 weeks for as long as benefit is shown. Patients will also undergo neurological exams and blood collection before beginning treatment, after each course of oxaliplatin, and after finishing treatment.
Important: For more details about this trial, refer to the Health Professional version 6 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 7.
Trial Contact Information
Trial Lead Organizations GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie  | | | | Philippe Lechat, Protocol chair | | | |
Trial Sites
| Registry Information | | | Official Title | | Study of the Relationship Between the Rate of Residual Platinum in the Blood and the Incidence of Persistent Neurotoxicity in Patients Treated for Gastrointestinal Cancer With Oxaliplatin | | | Trial Start Date | | 2005-10-10 | | | Registered in ClinicalTrials.gov | | NCT00274885 8 | | | Date Submitted to PDQ | | 2005-09-14 | | | Information Last Verified | | 2007-05-08 |
Glossary Terms
blood
A tissue with red blood cells, white blood cells, platelets, and other substances suspended in fluid called plasma. Blood takes oxygen and nutrients to the tissues, and carries away wastes.
cancer (KAN-ser)
A term for
diseases in which abnormal cells divide without control and
can invade nearby tissues. Cancer cells can also spread to
other parts of the body through the blood and lymph
systems. There are several main types of cancer. Carcinoma
is cancer that begins in the skin or in tissues that line
or cover internal organs. Sarcoma is cancer that begins in
bone, cartilage, fat, muscle, blood vessels, or other
connective or supportive tissue. Leukemia is cancer that
starts in blood-forming tissue such as the bone marrow, and
causes large numbers of abnormal blood cells to be produced
and enter the blood. Lymphoma and multiple myeloma are
cancers that begin in the cells of the immune system.
Central nervous system cancers are cancers that begin in
the tissues of the brain and spinal cord.
CNS
The brain and spinal cord. Also called central nervous system.
eligibility criteria (EH-lih-jih-BIH-lih-tee kry-TEER-ee-uh)
In clinical trials, requirements that must be met for an individual to be included in a study. These requirements help make sure that patients in a trial are similar to each other in terms of specific factors such as age, type and stage of cancer, general health, and previous treatment. When all participants meet the same eligibility criteria, it gives researchers greater confidence that results of the study are caused by the intervention being tested and not by other factors.
gastrointestinal (GAS-troh-in-TES-tih-nul)
Refers to the stomach and intestines. Also called GI.
infusion (in-FYOO-zhun)
A method of putting fluids, including drugs, into the bloodstream. Also called intravenous infusion.
neurological exam (NOOR-oh-LAH-jih-kul eg-ZAM)
A series of questions and tests to check brain, spinal cord, and nerve function. The exam checks a person’s mental status, coordination, ability to walk, and how well the muscles, sensory systems, and deep tendon reflexes work.
neurotoxicity (NOOR-oh-tok-SIH-sih-tee)
The tendency of some treatments to cause damage to the nervous system.
oxaliplatin (ok-SAL-ih-pla-tin)
A drug used together with other drugs to treat colorectal cancer that is advanced or has come back. It is also being studied in the treatment of other types of cancer. Oxaliplatin attaches to DNA in cells and may kill cancer cells. It is a type of platinum compound. Also called Eloxatin.
phase IV trial
After a treatment has been approved and is being marketed, it is studied in a phase IV trial to evaluate side effects that were not apparent in the phase III trial. Thousands of people are involved in a phase IV trial.
platinum
A metal that is an important component of some anticancer drugs, such as cisplatin and carboplatin.
regimen
A treatment plan that specifies the dosage, the schedule, and the duration of treatment.
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Table of Links
| 1 | http://www.cancer.gov/clinicaltrials/learning |
| 2 | http://www.cancer.gov/cancertopics/factsheet/Information/clinical-trials |
| 3 | http://www.cancer.gov/clinicaltrials/learning/questions-to-ask-about-participat
ing |
| 4 | http://www.nlm.nih.gov/medlineplus/druginformation.html |
| 5 | http://www.cancer.gov/clinicaltrials/GERCOR-TAUROX#EntryCriteria_CDR0000454401 |
| 6 | http://www.cancer.gov/clinicaltrials/GERCOR-TAUROX |
| 7 | http://cancer.gov/clinicaltrials |
| 8 | http://clinicaltrials.gov/ct/show/NCT00274885 |
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