Clinical trial NCT00695032: Kidney Damage in Patients Receiving Cisplatin and Ifosfamide for Solid Tumors
Official title: Biologic Evaluation of Renal Toxicity of Cisplatin and Ifosfamide (TOXIPLAT)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Chemotherapeutic Agent Toxicity
Renal Toxicity
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: renal toxicity
chemotherapeutic agent toxicity
unspecified adult solid tumor, protocol specific
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2008-06-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: Evolution of different biomarkers
measure: Sensitivity, specificity, and predictive value (positive and negative) of different markers
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Claudius Regaud
Study officials:
affiliation: Institut Claudius Regaud
name: Christine Chevreau-Dalbianco, MD
role: STUDY_CHAIR
References: