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2005-10
N/A
N/A
58
NCT00274885
National Cancer Institute (NCI)
National Cancer Institute (NCI)
INTERVENTIONAL
Relationship Between Platinum Levels in the Blood and Neurotoxicity in Patients Who Are Receiving Oxaliplatin for Gastrointestinal Cancer
RATIONALE: 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. PURPOSE: 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.
OBJECTIVES: Primary * Determine the relationship between residual platinum levels in the blood and persistent neurotoxicity in patients receiving oxaliplatin for gastrointestinal cancer. Secondary * Determine the pharmacokinetics of oxaliplatin in these patients. OUTLINE: This is an open-label, nonrandomized, multicenter study. Patients receive oxaliplatin IV over 2 hours. Treatment repeats every 2-3 weeks in the absence of disease progression or unacceptable toxicity. Neurological function and platinum levels in the blood are assessed at baseline, after each course of oxaliplatin, and at the end of study treatment. PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2006-01-10 | N/A | 2011-12-02 |
2006-01-10 | N/A | 2011-12-05 |
2006-01-11 | N/A | 2007-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
N/A
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Relationship between residual platinum levels in the blood and persistent neurotoxicity |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Pharmacokinetics |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
