Relationship Between Platinum Levels in the Blood and Neu... | NCT00274885 | Trialant
NCT00274885
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Status
Unknown status
Last Update Posted
Dec 5, 2011Estimated
Enrollment
58Estimated
Phase
Phase 4
Conditions
Cancer
Interventions
oxaliplatin
management of therapy complications
Countries
France
Protocol Section
Identification Module
NCT ID
NCT00274885
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000454401
Secondary IDs
ID
Type
Description
Link
GERCOR-TAUROX
SANOFI-GERCOR-TAUROX
EU-20573
Brief Title
Relationship Between Platinum Levels in the Blood and Neurotoxicity in Patients Who Are Receiving Oxaliplatin for Gastrointestinal Cancer
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
Acronym
Not provided
Organization
National Cancer Institute (NCI)NIH
Status Module
Record Verification Date
May 2007
Overall Recruitment Status or Expanded Access Status
Unknown status
Last Known Status
Recruiting
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2005
Primary Completion Date
Not provided
Completion Date
Not provided
First Submitted Date
Jan 10, 2006
First Submission Date that Met QC Criteria
Jan 10, 2006
First Posted Date
Jan 11, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
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.
Conditions Module
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
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 4
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
58Estimated
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
oxaliplatin
Drug
management of therapy complications
Procedure
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Relationship between residual platinum levels in the blood and persistent neurotoxicity
Secondary Outcomes
Measure
Description
Time Frame
Pharmacokinetics
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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