NCT00695032

Kidney Damage in Patients Receiving Cisplatin and Ifosfamide for Solid Tumors

Biologic Evaluation of Renal Toxicity of Cisplatin and Ifosfamide (TOXIPLAT)

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chemotherapeutic Agent Toxicity
• Renal Toxicity
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	ifosfamide
OTHER	laboratory biomarker analysis

Timeline

• Start date: 2007-10-01
• Primary completion: 2012-09-01
• First posted: 2008-06-11
• Last updated: 2014-11-05

Locations

1 site across 1 country: France