Kidney Damage in Patients Receiving Cisplatin and Ifosfamide for Solid Tumors
|ClinicalTrials.gov Identifier: NCT00695032|
Recruitment Status : Suspended
First Posted : June 11, 2008
Last Update Posted : November 5, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Chemotherapeutic Agent Toxicity Renal Toxicity Unspecified Adult Solid Tumor, Protocol Specific||Drug: cisplatin Drug: ifosfamide Other: laboratory biomarker analysis||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Biologic Evaluation of Renal Toxicity of Cisplatin and Ifosfamide (TOXIPLAT)|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||September 2012|
- Evolution of different biomarkers
- Sensitivity, specificity, and predictive value (positive and negative) of different markers
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00695032
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Study Chair:||Christine Chevreau-Dalbianco, MD||Institut Claudius Regaud|