NCT00274885

Brief 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. 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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_4 cancer

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2006

Completed
Last Updated

December 5, 2011

Status Verified

May 1, 2007

First QC Date

January 10, 2006

Last Update Submit

December 2, 2011

Conditions

Cancer

Keywords

neurotoxicitycarcinoma of the appendixrecurrent anal cancerstage I anal cancerstage II anal cancerstage IIIA anal cancerstage IIIB anal cancerstage IV anal cancerlocalized extrahepatic bile duct cancerrecurrent extrahepatic bile duct cancerunresectable extrahepatic bile duct cancerlocalized gallbladder cancerrecurrent gallbladder cancerunresectable gallbladder cancerrecurrent gastric cancerstage IV gastric cancerrecurrent colon cancerrecurrent rectal cancerrecurrent esophageal cancerlocalized gastrointestinal carcinoid tumormetastatic gastrointestinal carcinoid tumorrecurrent gastrointestinal carcinoid tumorregional gastrointestinal carcinoid tumorgastrointestinal stromal tumoradvanced adult primary liver cancerlocalized resectable adult primary liver cancerlocalized unresectable adult primary liver cancerrecurrent adult primary liver cancerrecurrent pancreatic cancerstage I pancreatic cancerstage II pancreatic cancerstage III pancreatic cancerrecurrent small intestine cancersmall intestine adenocarcinomasmall intestine leiomyosarcomasmall intestine lymphomastage IV pancreatic cancermetastatic extrahepatic bile duct cancermetastatic gallbladder cancerstage IA gastric cancerstage IB gastric cancerstage IIA gastric cancerstage IIB gastric cancerstage IIIA gastric cancerstage IIIB gastric cancerstage IIIC gastric cancerstage I colon cancerstage IIA colon cancerstage IIB colon cancerstage IIIA colon cancerstage IIIB colon cancerstage IIIC colon cancerstage IVA colon cancerstage IVB colon cancerstage I rectal cancerstage IIA rectal cancerstage IIB rectal cancerstage IIC rectal cancerstage IIIA rectal cancerstage IIIB rectal cancerstage IIIC rectal cancerstage IVA rectal cancerstage IVB rectal cancerstage IA esophageal cancerstage IB esophageal cancerstage IIA esophageal cancerstage IIB esophageal cancerstage IIIA esophageal cancerstage IIIB esophageal cancerstage IIIC esophageal cancerstage IV esophageal cancer

Outcome Measures

Primary Outcomes (1)

  • Relationship between residual platinum levels in the blood and persistent neurotoxicity

Secondary Outcomes (1)

  • Pharmacokinetics

Interventions

oxaliplatinDRUG
management of therapy complicationsPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

CHU de Grenoble - Hopital Michallon

Grenoble, 38043, France

RECRUITING

Centre Hospital Universitaire Hop Huriez

Lille, 59037, France

RECRUITING

Clinique Saint Jean

Lyon, 69008, France

RECRUITING

Hopital Saint Antoine

Paris, 75571, France

RECRUITING

CHU Pitie-Salpetriere

Paris, 75651, France

RECRUITING

Hopital Tenon

Paris, 75970, France

RECRUITING

MeSH Terms

Conditions

NeoplasmsNeurotoxicity SyndromesAppendiceal NeoplasmsAnus NeoplasmsBile Duct NeoplasmsGallbladder NeoplasmsStomach NeoplasmsColonic NeoplasmsRectal NeoplasmsEsophageal NeoplasmsGastrointestinal Stromal TumorsCarcinoma, HepatocellularPancreatic Neoplasms

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

Nervous System DiseasesPoisoningChemically-Induced DisordersCecal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesCecal DiseasesIntestinal DiseasesColorectal NeoplasmsAnus DiseasesRectal DiseasesBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract DiseasesGallbladder DiseasesStomach DiseasesColonic DiseasesHead and Neck NeoplasmsEsophageal DiseasesNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialLiver NeoplasmsLiver DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Philippe Lechat

    CHU Pitie-Salpetriere

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 11, 2006

Study Start

October 1, 2005

Last Updated

December 5, 2011

Record last verified: 2007-05

Locations

FR(6)