Kidney Damage in Patients Receiving Cisplatin and Ifosfamide for Solid Tumors
- Conditions
- Chemotherapeutic Agent ToxicityRenal ToxicityUnspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00695032
- Lead Sponsor
- Institut Claudius Regaud
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* Identify and evaluate the early biomarkers of renal toxicity in patients with solid tumors treated with cisplatin and ifosfamide.
Secondary
* 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Evolution of different biomarkers Sensitivity, specificity, and predictive value (positive and negative) of different markers
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institut Claudius Regaud
🇫🇷Toulouse, France