CancerPhase 4NCT00274885
Relationship Between Platinum Levels in the Blood and Neurotoxicity in Patients Who Are Receiving Oxaliplatin for Gastrointestinal Cancer
A Phase 4 study testing oxaliplatin and management of therapy complications in people with Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 6 sites in France.
Trial summary
RATIONALE: Learning about the relationship between platinum levels in the blood and neurotoxicity in patients receiving oxaliplatin may help plan treatment and may help patients live more comfortably. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- oxaliplatin and management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 6 sitesFrance
- Study dates
- Oct 2005to not given
- Phase
- Phase 4
- 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
DISEASE CHARACTERISTICS:
- Diagnosis of gastrointestinal cancer
- Receiving or planning to receive 8 months of oxaliplatin-based chemotherapy
- No pre-existing neuropathy
- No CNS disease or cerebral metastases
PATIENT CHARACTERISTICS:
- WHO 0-1
- Life expectancy ≥ 12 weeks
- No biliary or gastro-duodenal obstruction
- No familial, social, geographical, or psychological condition that would preclude study treatment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No other concurrent drug or agent that is potentially neurotoxic
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
CHU de Grenoble - Hopital Michallon
Grenoble, 38043
Christine Rebischung, 33-4-7676-5451
- Recruiting
Centre Hospital Universitaire Hop Huriez
Lille, 59037
Mohamed Hebbar, MD, 33-3-2044-5461, m-hebbar@chru-lille.fr
- Recruiting
Clinique Saint Jean
Lyon, 69008
Gerard Lledo, 33-4-7878-1051
- Recruiting
Hopital Saint Antoine
Paris, 75571
Olivier Rosmorduc, MD, PhD, 33-1-4928-2382, olivier.rosmorduc@sat.aphp.fr
- Recruiting
CHU Pitie-Salpetriere
Paris, 75651
Jean-Baptiste Meric, MD, 33-1-4216-0471, jeanbaptiste.meric@psl.ap-hop-paris.fr
- Recruiting
Hopital Tenon
Paris, 75970
Thierry Andre, MD, 33-1-6177-0708, thierry.andre@tnn.ap-hop-paris.fr
About this study
Official title: Study of the Relationship Between the Rate of Residual Platinum in the Blood and the Incidence of Persistent Neurotoxicity in Patients Treated for Gastrointestinal Cancer With Oxaliplatin
RATIONALE: Learning about the relationship between platinum levels in the blood and neurotoxicity in patients receiving oxaliplatin may help plan treatment and may help patients live more comfortably.
PURPOSE: This phase IV trial is studying the relationship between platinum levels in the blood and neurotoxicity in patients who are receiving oxaliplatin for gastrointestinal cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the relationship between residual platinum levels in the blood and persistent neurotoxicity in patients receiving oxaliplatin for gastrointestinal cancer.
Secondary
- Determine the pharmacokinetics of oxaliplatin in these patients.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive oxaliplatin IV over 2 hours. Treatment repeats every 2-3 weeks in the absence of disease progression or unacceptable toxicity.
Neurological function and platinum levels in the blood are assessed at baseline, after each course of oxaliplatin, and at the end of study treatment.
PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.
- Conditions
- Cancer
- Being tested
- oxaliplatin, management of therapy complications
- Keywords
- neurotoxicity, carcinoma of the appendix, recurrent anal cancer, stage I anal cancer, stage II anal cancer, stage IIIA anal cancer, stage IIIB anal cancer, stage IV anal cancer, localized extrahepatic bile duct cancer, recurrent extrahepatic bile duct cancer, unresectable extrahepatic bile duct cancer, localized gallbladder cancer, recurrent gallbladder cancer, unresectable gallbladder cancer, recurrent gastric cancer, stage IV gastric cancer, recurrent colon cancer, recurrent rectal cancer, recurrent esophageal cancer, localized gastrointestinal carcinoid tumor
- Medical subject headings
- Neoplasms, Neurotoxicity Syndromes, Appendiceal Neoplasms, Anus Neoplasms, Bile Duct Neoplasms, Gallbladder Neoplasms, Stomach Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatinDrug
management of therapy complicationsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between residual platinum levels in the blood and persistent neurotoxicity
Secondary outcomes (1)
Pharmacokinetics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2006 (estimated)
- Study startOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Investigators
- Philippe Lechat, Study chair, CHU Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274885
- Sponsor's protocol ID
- CDR0000454401
- Other IDs
- GERCOR-TAUROX, SANOFI-GERCOR-TAUROX, EU-20573
- Status last verified
- May 2007
- First submitted
- 10 Jan 2006
- Last updated
- 5 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Relationship Between the Rate of Residual Platinum in the Blood and the Incidence of Persistent Neurotoxicity in Patients Treated for Gastrointestinal Cancer With Oxaliplatin
- ClinicalTrials.gov ID
- NCT00274885
- Acronym / sponsor ID
- CDR0000454401
- Conditions
- Cancer
- Keywords
- neurotoxicity, carcinoma of the appendix, recurrent anal cancer, stage I anal cancer, stage II anal cancer, stage IIIA anal cancer, stage IIIB anal cancer, stage IV anal cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Study start
- Oct 2005
- First posted
- 11 Jan 2006 (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: Learning about the relationship between platinum levels in the blood and neurotoxicity in patients receiving oxaliplatin may help plan treatment and may help patients live more comfortably.
PURPOSE: This phase IV trial is studying the relationship between platinum levels in the blood and neurotoxicity in patients who are receiving oxaliplatin for gastrointestinal cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the relationship between residual platinum levels in the blood and persistent neurotoxicity in patients receiving oxaliplatin for gastrointestinal cancer.
Secondary
- Determine the pharmacokinetics of oxaliplatin in these patients.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive oxaliplatin IV over 2 hours. Treatment repeats every 2-3 weeks in the absence of disease progression or unacceptable toxicity.
Neurological function and platinum levels in the blood are assessed at baseline, after each course of oxaliplatin, and at the end of study treatment.
PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| oxaliplatin | Drug | – |
| management of therapy complications | Procedure or surgery | – |
Primary outcome
Relationship between residual platinum levels in the blood and persistent neurotoxicity
1 secondary outcome
Pharmacokinetics
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2011.
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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.
Philippe Lechat study chair
CHU Pitie-Salpetriere
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oxaliplatin and management of therapy complications in people with Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 5 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between residual platinum levels in the blood and persistent neurotoxicity. 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 Dec 2011.