Biologic Evaluation of Renal Toxicity of Cisplatin and Ifosfamide (TOXIPLAT)
18 Years
N/A
Both
Chemotherapeutic Agent Toxicity, Renal Toxicity, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Biologic Evaluation of Renal Toxicity of Cisplatin and Ifosfamide (TOXIPLAT)
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of a solid tumor
- Any location allowed
- Metastatic disease allowed
- Planned treatment comprising cisplatin and/or ifosfamide as standard chemotherapy
PATIENT CHARACTERISTICS:
Inclusion criteria:
- Life expectancy > 3 months
- Creatinine clearance ≥ 60 mL/min
- Must be available for follow up
- Not pregnant or nursing
- Not under guardianship or in prison
Exclusion criteria:
- Prior drug-related nephrotoxicity
- Acute, uncontrolled urinary infection or > 48-hours
- Pre-existing hemorrhagic cystitis
- Weak bladder
- Bilateral obstruction of urinary tract
- Insufficient, severe bone marrow hypoplasia
- Cardiorespiratory condition contraindicating hyperhydration
- Hearing impairment
- Hypersensitivity to cisplatin or products containing platinum
- Major psychiatric condition (severe depression, psychosis, dementia)
PRIOR CONCURRENT THERAPY:
- No prior yellow fever vaccine, live attenuated vaccine, or phenytoin
- No concurrent participation in another biomedical study
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Primary Purpose: Treatment
Outcome Measure:
Evolution of different biomarkers
Safety Issue:
No
Principal Investigator
Christine Chevreau-Dalbianco, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Institut Claudius Regaud
Authority:
Unspecified
Study ID:
CDR0000589590
NCT ID:
NCT00695032
Start Date:
October 2007
Completion Date:
Related Keywords:
- Chemotherapeutic Agent Toxicity
- Renal Toxicity
- Unspecified Adult Solid Tumor, Protocol Specific
- renal toxicity
- chemotherapeutic agent toxicity
- unspecified adult solid tumor, protocol specific
- Neoplasms
- Kidney Diseases
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