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Kidney Damage in Patients Receiving Cisplatin and Ifosfamide for Solid Tumors

Sponsor
Institut Claudius Regaud (Other)
Overall Status
Suspended
CT.gov ID
NCT00695032
Collaborator
(none)
80
Enrollment
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Primary Purpose:
Treatment
Official Title:
Biologic Evaluation of Renal Toxicity of Cisplatin and Ifosfamide (TOXIPLAT)
Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
Sep 1, 2012

Outcome Measures

Primary Outcome Measures

  1. Evolution of different biomarkers []

  2. Sensitivity, specificity, and predictive value (positive and negative) of different markers []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Institut Claudius Regaud Toulouse France 31052

Sponsors and Collaborators

  • Institut Claudius Regaud

Investigators

  • Study Chair: Christine Chevreau-Dalbianco, MD, Institut Claudius Regaud

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT00695032
Other Study ID Numbers:
  • 07GENE03
  • ICREGAUD-TOXIPLAT
  • ICREGAUD-07-GENE-03
  • EUDRACT-2007-004251-12
  • INCA-RECF0479
First Posted:
Jun 11, 2008
Last Update Posted:
Nov 5, 2014
Last Verified:
Nov 1, 2014
Keywords provided by Institut Claudius Regaud
renal toxicity
chemotherapeutic agent toxicity
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
Ifosfamide

Study Results

No Results Posted as of Nov 5, 2014