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Oxaliplatin Plus Irinotecan in Treating Patients With Metastatic Gastrointestinal Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003427
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of oxaliplatin plus irinotecan in treating patients with previously treated metastatic gastrointestinal cancer that has not responded to previous treatment.


Condition Intervention Phase
Anal Cancer
Colorectal Cancer
Esophageal Cancer
Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Gastric Cancer
Gastrointestinal Carcinoid Tumor
Liver Cancer
Pancreatic Cancer
Small Intestine Cancer
Drug: irinotecan hydrochloride
Drug: oxaliplatin
Phase I

MedlinePlus related topics:   Anal Cancer    Cancer    Carcinoid Tumors    Colorectal Cancer    Esophageal Cancer    Esophagus Disorders    Intestinal Cancer    Liver Cancer    Pancreatic Cancer    Stomach Cancer   

ChemIDplus related topics:   Irinotecan    Irinotecan hydrochloride    Oxaliplatin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase I Study to Evaluate the Combination Chemotherapy Regimen of Oxaliplatin Plus Irinotecan in Previously Treated Patients With Metastatic Gastrointestinal Cancer

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   36
Study Start Date:   April 1998

Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) for the combination chemotherapy regimen of oxaliplatin plus irinotecan when both drugs are given once a week for four weeks, followed by a two week rest, in patients with metastatic gastrointestinal cancer. II. Evaluate the toxicities of this combination chemotherapy when administered in this manner. III. Determine the pharmacokinetics of platinum and irinotecan at the MTD for this combination chemotherapy in this patient population.

OUTLINE: This is a dose escalation study. Patients receive oxaliplatin IV over 120 minutes, immediately followed by irinotecan IV over 30 minutes, weekly for 4 weeks (days 1, 8, 15, and 22). Courses are repeated every 42 days. Treatment continues in the absence of unacceptable side effects or disease progression. Sequential dose escalation of oxaliplatin is followed by sequential dose escalation of irinotecan. Dose escalation in cohorts of 3-6 patients each continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxic effects. Patients are followed approximately every 2-3 months.

PROJECTED ACCRUAL: A total of 2-36 patients will be accrued for this study within 18-36 months.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic gastrointestinal carcinoma Measurable disease No CNS metastases No obstruction or partial obstruction of GI tract No obstruction of genitourinary tract

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 125,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No uncontrolled high blood pressure, unstable angina, active congestive heart failure, myocardial infarction within prior 6 months, or serious uncontrolled cardiac arrhythmia Neurological: No concurrent symptomatic peripheral sensory neuropathy Other: No active or uncontrolled infection Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cisplatin, oxaliplatin, nitrosoureas, or mitomycin C 1 or 2 prior chemotherapy regimens allowed (including irinotecan) Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy to whole pelvis, 30% or greater of bone marrow, and site of measurable disease At least 4 weeks since prior radiation therapy and recovered Surgery: Not specified

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003427

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center    
      New York, New York, United States, 10021

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Nancy E. Kemeny, MD     Memorial Sloan-Kettering Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000066452, MSKCC-98034, NCI-G98-1450
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003427
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer  
stage IV gastric cancer  
recurrent gastric cancer  
recurrent pancreatic cancer  
stage IV rectal cancer  
recurrent colon cancer  
recurrent rectal cancer  
stage IV anal cancer  
recurrent anal cancer  
stage IV esophageal cancer  
recurrent esophageal cancer  
metastatic gastrointestinal carcinoid tumor
recurrent gastrointestinal carcinoid tumor
advanced adult primary liver cancer
recurrent adult primary liver cancer
unresectable gallbladder cancer
recurrent gallbladder cancer
unresectable extrahepatic bile duct cancer
recurrent extrahepatic bile duct cancer
recurrent small intestine cancer
stage IV pancreatic cancer

Study placed in the following topic categories:
Gallbladder Diseases
Liver Diseases
Rectal Neoplasms
Pancreatic Neoplasms
Colonic Diseases
Rectal Diseases
Duodenal Neoplasms
Neuroepithelioma
Rectal cancer
Endocrine Gland Neoplasms
Digestive System Neoplasms
Endocrine System Diseases
Stomach cancer
Malignant Carcinoid Syndrome
Camptothecin
Gall bladder cancer
Carcinoma
Neuroectodermal Tumors
Bile Duct Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Carcinoid Tumor
Bile Duct Neoplasms
Esophageal Diseases
Gallbladder Neoplasms
Anus Neoplasms
Neoplasms, Glandular and Epithelial
Gastrointestinal Diseases
Esophageal Neoplasms
Irinotecan

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Ileal Diseases
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Jejunal Diseases
Therapeutic Uses
Anus Diseases
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on October 10, 2008




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