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

Study Overview
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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.

Official Title
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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

Conditions
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Cancer

Intervention / Treatment
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* Drug: oxaliplatin
* Procedure: management of therapy complications


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: oxaliplatin|nan|
|Procedure: management of therapy complications|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between residual platinum levels in the blood and persistent neurotoxicity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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