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Kidney Damage in Patients Receiving Cisplatin and Ifosfamide for Solid Tumors

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT00695032
First received: June 7, 2008
Last updated: November 4, 2014
Last verified: November 2014
  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 [ Designated as safety issue: No ]
  • Sensitivity, specificity, and predictive value (positive and negative) of different markers [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

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
Study First Received: June 7, 2008
Last Updated: November 4, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

Additional relevant MeSH terms:
Cisplatin
Ifosfamide
Isophosphamide mustard
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014