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

NCT ID: NCT00274885

Last Updated: 2011-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Brief Summary

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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

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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

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Cancer

Keywords

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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 stage II pancreatic cancer stage III pancreatic cancer recurrent small intestine cancer small intestine adenocarcinoma small intestine leiomyosarcoma small intestine lymphoma stage IV pancreatic cancer metastatic extrahepatic bile duct cancer metastatic gallbladder cancer stage IA gastric cancer stage IB gastric cancer stage IIA gastric cancer stage IIB gastric cancer stage IIIA gastric cancer stage IIIB gastric cancer stage IIIC gastric cancer stage I colon cancer stage IIA colon cancer stage IIB colon cancer stage IIIA colon cancer stage IIIB colon cancer stage IIIC colon cancer stage IVA colon cancer stage IVB colon cancer stage I rectal cancer stage IIA rectal cancer stage IIB rectal cancer stage IIC rectal cancer stage IIIA rectal cancer stage IIIB rectal cancer stage IIIC rectal cancer stage IVA rectal cancer stage IVB rectal cancer stage IA esophageal cancer stage IB esophageal cancer stage IIA esophageal cancer stage IIB esophageal cancer stage IIIA esophageal cancer stage IIIB esophageal cancer stage IIIC esophageal cancer stage IV esophageal cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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oxaliplatin

Intervention Type DRUG

management of therapy complications

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER

Sponsor Role lead

Principal Investigators

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Philippe Lechat

Role: STUDY_CHAIR

CHU Pitie-Salpetriere

Locations

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CHU de Grenoble - Hopital Michallon

Grenoble, , France

Site Status RECRUITING

Centre Hospital Universitaire Hop Huriez

Lille, , France

Site Status RECRUITING

Clinique Saint Jean

Lyon, , France

Site Status RECRUITING

Hopital Saint Antoine

Paris, , France

Site Status RECRUITING

CHU Pitie-Salpetriere

Paris, , France

Site Status RECRUITING

Hopital Tenon

Paris, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Christine Rebischung

Role: primary

Mohamed Hebbar, MD

Role: primary

Gerard Lledo

Role: primary

Olivier Rosmorduc, MD, PhD

Role: primary

Jean-Baptiste Meric, MD

Role: primary

Thierry Andre, MD

Role: primary

Other Identifiers

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GERCOR-TAUROX

Identifier Type: -

Identifier Source: secondary_id

SANOFI-GERCOR-TAUROX

Identifier Type: -

Identifier Source: secondary_id

EU-20573

Identifier Type: -

Identifier Source: secondary_id

CDR0000454401

Identifier Type: -

Identifier Source: org_study_id