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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00695032 |
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Date of registration:
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07/06/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Kidney Damage in Patients Receiving Cisplatin and Ifosfamide for Solid Tumors
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Scientific title:
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Biologic Evaluation of Renal Toxicity of Cisplatin and Ifosfamide (TOXIPLAT) |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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80 |
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Recruitment status: |
Suspended |
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URL:
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http://clinicaltrials.gov/show/NCT00695032 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Christine Chevreau-Dalbianco, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut Claudius Regaud |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Unspecified Adult Solid Tumor, Protocol Specific
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Renal Toxicity
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Chemotherapeutic Agent Toxicity
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Intervention(s)
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Drug: cisplatin
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Other: laboratory biomarker analysis
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Drug: ifosfamide
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Primary Outcome(s)
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Sensitivity, specificity, and predictive value (positive and negative) of different markers
[Time Frame: No]
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Evolution of different biomarkers
[Time Frame: No]
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Secondary ID(s)
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ICREGAUD-07-GENE-03
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INCA-RECF0479
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EUDRACT-2007-004251-12
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07GENE03
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ICREGAUD-TOXIPLAT
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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