NCT00695032

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2008

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

4.9 years

First QC Date

June 7, 2008

Last Update Submit

November 4, 2014

Conditions

Chemotherapeutic Agent ToxicityRenal ToxicityUnspecified Adult Solid Tumor, Protocol Specific

Keywords

renal toxicitychemotherapeutic agent toxicityunspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (2)

  • Evolution of different biomarkers

  • Sensitivity, specificity, and predictive value (positive and negative) of different markers

Interventions

cisplatinDRUG
ifosfamideDRUG
laboratory biomarker analysisOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Claudius Regaud

Toulouse, 31052, France

Location

MeSH Terms

Interventions

CisplatinIfosfamide

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Christine Chevreau-Dalbianco, MD

    Institut Claudius Regaud

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2008

First Posted

June 11, 2008

Study Start

October 1, 2007

Primary Completion

September 1, 2012

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations

FR(1)