Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Biologic Evaluation of Renal Toxicity of Cisplatin and Ifosfamide (TOXIPLAT)
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.
Status | Suspended |
Enrollment | 80 |
Est. completion date | |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Institut Claudius Regaud | Toulouse |
Lead Sponsor | Collaborator |
---|---|
Institut Claudius Regaud |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evolution of different biomarkers | No | ||
Primary | Sensitivity, specificity, and predictive value (positive and negative) of different markers | No |
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