Status:
SUSPENDED
Kidney Damage in Patients Receiving Cisplatin and Ifosfamide for Solid Tumors
Lead Sponsor:
Institut Claudius Regaud
Conditions:
Chemotherapeutic Agent Toxicity
Renal Toxicity
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 bi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00695032
Start Date
October 1 2007
Last Update
November 5 2014
Active Locations (1)
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1
Institut Claudius Regaud
Toulouse, France, 31052