Kidney Damage in Patients Receiving Cisplatin and Ifosfamide for Solid Tumors

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00695032
• Other study ID #: 07GENE03
• Secondary ID: ICREGAUD-TOXIPLA
• Status: Suspended
• Phase: N/A
• First received: June 7, 2008
• Last updated: November 4, 2014
• Start date: October 2007

Study information

• Verified date: November 2014
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 80
• 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemotherapeutic Agent Toxicity
• Renal Toxicity
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• cisplatin

• ifosfamide

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
France	Institut Claudius Regaud	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

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