Kidney Damage in Patients Receiving Cisplatin and Ifosfamide for Solid Tumors
RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is evaluating kidney damage in patients receiving cisplatin and ifosfamide for solid tumors.
Chemotherapeutic Agent Toxicity
Unspecified Adult Solid Tumor, Protocol Specific
Other: laboratory biomarker analysis
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Biologic Evaluation of Renal Toxicity of Cisplatin and Ifosfamide (TOXIPLAT)|
- Evolution of different biomarkers [ Designated as safety issue: No ]
- Sensitivity, specificity, and predictive value (positive and negative) of different markers [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
- Identify and evaluate the early biomarkers of renal toxicity in patients with solid tumors treated with cisplatin and ifosfamide.
- Correlate the modification of biomarker studies and blood concentrations of cisplatin.
OUTLINE: Patients receive standard chemotherapy comprising cisplatin and/or ifosfamide.
Blood and urine samples are collected on days 1 and 2 (or day 3 if receiving ifosfamide only) during the first 3 courses. Samples are analyzed to determine plasma concentrations of residual cisplatin and to obtain urinary-protein profiles to measure renal toxicity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00695032
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Study Chair:||Christine Chevreau-Dalbianco, MD||Institut Claudius Regaud|