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

Primary Purpose

Cancer

Status

Unknown status

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

oxaliplatin

management of therapy complications

About this trial

This is an interventional treatment trial for Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU de Grenoble - Hopital MichallonRecruiting
Centre Hospital Universitaire Hop HuriezRecruiting
Clinique Saint JeanRecruiting
Hopital Saint AntoineRecruiting
CHU Pitie-SalpetriereRecruiting
Hopital TenonRecruiting

Outcomes

Primary Outcome Measures

Relationship between residual platinum levels in the blood and persistent neurotoxicity

Secondary Outcome Measures

Pharmacokinetics

Full Information

NCT ID

NCT00274885

First Posted

January 10, 2006

Last Updated

December 2, 2011

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

1. Study Identification

Unique Protocol Identification Number

NCT00274885

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2007

Overall Recruitment Status

Unknown status

Study Start Date

October 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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, 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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

58 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

oxaliplatin

Intervention Type

Procedure

Intervention Name(s)

management of therapy complications

Primary Outcome Measure Information:

Title

Relationship between residual platinum levels in the blood and persistent neurotoxicity

Secondary Outcome Measure Information:

Title

Pharmacokinetics

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philippe Lechat

Organizational Affiliation

CHU Pitie-Salpetriere

Official's Role

Study Chair

Facility Information:

Facility Name

CHU de Grenoble - Hopital Michallon

City

Grenoble

ZIP/Postal Code

38043

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christine Rebischung

Phone

33-4-7676-5451

Facility Name

Centre Hospital Universitaire Hop Huriez

City

Lille

ZIP/Postal Code

59037

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohamed Hebbar, MD

Phone

33-3-2044-5461

m-hebbar@chru-lille.fr

Facility Name

Clinique Saint Jean

City

Lyon

ZIP/Postal Code

69008

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gerard Lledo

Phone

33-4-7878-1051

Facility Name

Hopital Saint Antoine

City

Paris

ZIP/Postal Code

75571

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Olivier Rosmorduc, MD, PhD

Phone

33-1-4928-2382

olivier.rosmorduc@sat.aphp.fr

Facility Name

CHU Pitie-Salpetriere

City

Paris

ZIP/Postal Code

75651

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-Baptiste Meric, MD

Phone

33-1-4216-0471

jeanbaptiste.meric@psl.ap-hop-paris.fr

Facility Name

Hopital Tenon

City

Paris

ZIP/Postal Code

75970

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thierry Andre, MD

Phone

33-1-6177-0708

thierry.andre@tnn.ap-hop-paris.fr

12. IPD Sharing Statement

Learn more about this trial

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

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