Biologic Evaluation of Renal Toxicity of Cisplatin and Ifosfamide (TOXIPLAT)


N/A
18 Years
N/A
Open (Enrolling)
Both
Chemotherapeutic Agent Toxicity, Renal Toxicity, Unspecified Adult Solid Tumor, Protocol Specific

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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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