Clinical trial NCT00274885: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-01-11
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Relationship between residual platinum levels in the blood and persistent neurotoxicity
Secondary outcomes:
measure: Pharmacokinetics
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU de Grenoble - Hopital Michallon
city: Lille
country: France
facility: Centre Hospital Universitaire Hop Huriez
city: Lyon
country: France
facility: Clinique Saint Jean
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: CHU Pitie-Salpetriere
city: Paris
country: France
facility: Hopital Tenon
Study officials:
affiliation: CHU Pitie-Salpetriere
name: Philippe Lechat
role: STUDY_CHAIR
References: