Kidney Damage in Patients Receiving Cisplatin and Ifosfamide for Solid Tumors - Full Text View

Sponsored by:	Institut Claudius Regaud
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00695032

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
Cancer-Related Problem/Condition Unspecified Adult Solid Tumor, Protocol Specific	Drug: cisplatin Drug: ifosfamide Procedure: laboratory biomarker analysis

MedlinePlus related topics: Cancer

Drug Information available for: Ifosfamide Cisplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized
Official Title:	Biologic Evaluation of Renal Toxicity of Cisplatin and Ifosfamide (TOXIPLAT)

Further study details as provided by National Cancer Institute (NCI):

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
Estimated Primary Completion Date:	October 2010 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695032

Locations

France
Institut Claudius Regaud	Recruiting
Toulouse, France, 31052
Contact: Contact Person 33-5-6142-4242 chevreau.christine@cluadiusregaud.fr

Sponsors and Collaborators

Institut Claudius Regaud

Investigators

Study Chair:

Christine Chevreau-Dalbianco, MD

Institut Claudius Regaud

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000589590, ICREGAUD-TOXIPLAT, ICREGAUD-07-GENE-03, EUDRACT-2007-004251-12, INCA-RECF0479
Study First Received:	June 7, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00695032
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

renal toxicity
chemotherapeutic agent toxicity
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Ifosfamide
Cisplatin
Mechlorethamine
Isophosphamide mustard

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009