Chemotherapeutic Agent ToxicityNCT00695032
Kidney Damage in Patients Receiving Cisplatin and Ifosfamide for Solid Tumors
A study testing cisplatin, ifosfamide and laboratory biomarker analysis in people with Chemotherapeutic Agent Toxicity and Renal Toxicity, run by Institut Claudius Regaud at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapeutic Agent Toxicity, Renal Toxicity, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- cisplatin, ifosfamide and laboratory biomarker analysis
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2007to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biologic Evaluation of Renal Toxicity of Cisplatin and Ifosfamide (TOXIPLAT)
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.
Read the 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.
- Conditions
- Chemotherapeutic Agent Toxicity, Renal Toxicity, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- cisplatin, ifosfamide, laboratory biomarker analysis
- Keywords
- renal toxicity, chemotherapeutic agent toxicity, unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
ifosfamideDrug
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of different biomarkers
Sensitivity, specificity, and predictive value (positive and negative) of different markers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startOct 2007
- Primary completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapeutic Agent ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Chevreau-Dalbianco, MD, Study chair, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695032
- Sponsor's protocol ID
- 07GENE03
- Other IDs
- ICREGAUD-TOXIPLAT, ICREGAUD-07-GENE-03, EUDRACT-2007-004251-12, INCA-RECF0479
- Status last verified
- Nov 2014
- First submitted
- 7 Jun 2008
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biologic Evaluation of Renal Toxicity of Cisplatin and Ifosfamide (TOXIPLAT)
- ClinicalTrials.gov ID
- NCT00695032
- Acronym / sponsor ID
- 07GENE03
- Conditions
- Chemotherapeutic Agent Toxicity, Renal Toxicity, Unspecified Adult Solid Tumor, Protocol Specific
- Keywords
- renal toxicity, chemotherapeutic agent toxicity, unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Sep 2012 (actual)
- First posted
- 11 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- Prior drug-related nephrotoxicity
- Acute, uncontrolled urinary infection or > 48-hours
- Pre-existing hemorrhagic cystitis
- Weak bladder
- Bilateral obstruction of urinary tract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisplatin | Drug | – |
| ifosfamide | Drug | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Evolution of different biomarkers
Sensitivity, specificity, and predictive value (positive and negative) of different markers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Chevreau-Dalbianco, MD study chair
Institut Claudius Regaud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cisplatin, ifosfamide and laboratory biomarker analysis in people with Chemotherapeutic Agent Toxicity and Renal Toxicity, run by Institut Claudius Regaud at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of different biomarkers. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2014.