Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Relationship Between Platinum Levels in the Blood and Neurotoxicity in Patients Who Are Receiving Oxaliplatin for Gastrointestinal Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00274885
First received: January 10, 2006
Last updated: December 2, 2011
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Cancer
Drug: oxaliplatin
Procedure: management of therapy complications
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Relationship between residual platinum levels in the blood and persistent neurotoxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Designated as safety issue: No ]

Estimated Enrollment: 58
Study Start Date: October 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274885

Locations
France
CHU de Grenoble - Hopital Michallon
Grenoble, France, 38043
Centre Hospital Universitaire Hop Huriez
Lille, France, 59037
Clinique Saint Jean
Lyon, France, 69008
Hopital Saint Antoine
Paris, France, 75571
CHU Pitie-Salpetriere
Paris, France, 75651
Hopital Tenon
Paris, France, 75970
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Study Chair: Philippe Lechat CHU Pitie-Salpetriere
  More Information

ClinicalTrials.gov Identifier: NCT00274885     History of Changes
Other Study ID Numbers: CDR0000454401  GERCOR-TAUROX  SANOFI-GERCOR-TAUROX  EU-20573 
Study First Received: January 10, 2006
Last Updated: December 2, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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
metastatic gastrointestinal carcinoid tumor
recurrent gastrointestinal carcinoid tumor
regional gastrointestinal carcinoid tumor
gastrointestinal stromal tumor
advanced adult primary liver cancer
localized resectable adult primary liver cancer
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
recurrent pancreatic cancer
stage I pancreatic cancer

Additional relevant MeSH terms:
Neurotoxicity Syndromes
Gastrointestinal Neoplasms
Nervous System Diseases
Poisoning
Chemically-Induced Disorders
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Oxaliplatin
Antineoplastic Agents

ClinicalTrials.gov processed this record on December 06, 2016