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Kidney Damage in Patients Receiving Cisplatin and Ifosfamide for Solid Tumors

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00695032
First Posted: June 11, 2008
Last Update Posted: November 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut Claudius Regaud
  Purpose

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.


Condition Intervention
Chemotherapeutic Agent Toxicity Renal Toxicity Unspecified Adult Solid Tumor, Protocol Specific Drug: cisplatin Drug: ifosfamide Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Biologic Evaluation of Renal Toxicity of Cisplatin and Ifosfamide (TOXIPLAT)

Resource links provided by NLM:


Further study details as provided by Institut Claudius Regaud:

Primary Outcome Measures:
  • Evolution of different biomarkers
  • Sensitivity, specificity, and predictive value (positive and negative) of different markers

Estimated Enrollment: 80
Study Start Date: October 2007
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00695032


Locations
France
Institut Claudius Regaud
Toulouse, France, 31052
Sponsors and Collaborators
Institut Claudius Regaud
Investigators
Study Chair: Christine Chevreau-Dalbianco, MD Institut Claudius Regaud
  More Information

Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT00695032     History of Changes
Other Study ID Numbers: 07GENE03
ICREGAUD-TOXIPLAT
ICREGAUD-07-GENE-03
EUDRACT-2007-004251-12
INCA-RECF0479
First Submitted: June 7, 2008
First Posted: June 11, 2008
Last Update Posted: November 5, 2014
Last Verified: November 2014

Keywords provided by Institut Claudius Regaud:
renal toxicity
chemotherapeutic agent toxicity
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Isophosphamide mustard
Cisplatin
Ifosfamide
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action