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Irinotecan in Treating Patients With Refractory Solid Tumors and Liver Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00037804
Recruitment Status : Completed
First Posted : May 22, 2002
Last Update Posted : August 14, 2009
Information provided by:

Brief Summary:
Drugs used in chemotherapy us different ways to stop tumor cells from dividing so they stop growing or die. Irinotecan may be effective in treating patients with refractory solid tumors and liver dysfunction.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor Chemotherapy Liver Dysfunction Neoplasms, Solid Tumor Drug: Irinotecan Phase 1

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary.

Inclusion Criteria: Histological proof of malignant solid tumor that is refractory to standard forms of therapy or for which no known curative therapy exists; Measurable or evaluable disease; At least 6 weeks since prior chemotherapy with nitrosoureas; At least 28 days since prior anticancer therapy and recovered; At least 4 weeks since prior radiation therapy and recovered; Age 18 years or older; SWOG 0-2; Life expectancy of at least 12 weeks; Segmented neutrophils with bands at least 1,500/mm3; Hemoglobin at least 9.0 g/dL and platelet count at least 100,000/mm3; Prothrombin time and partial thromboplastin time no greater than 2.0 times control; INR no greater than 3.0 times control; Concurrent use of coumadin allowed only if dose is stable and prothrombin time and INR is stable; Total serum bilirubin at least 1.5 but no greater than 5.0 times upper limit of normal; SGOT/SGPT no greater than 5 times upper limit of normal; SGOT/SGPT at least 1.5 but no greater than 20.0 times upper limit of normal; Creatinine no greater than 2

Exclusion Criteria: Patients expressing tumor markers as their only evidence of disease or who have previously irradiated areas that have not increased in size; Prior chemotherapy treatment with irinotecan and mitomycin; Prior abdominal and/or pelvic radiation therapy; Current history of hepatitis B infection or positive test for hepatitis B surface antigen; Hepatic encephalopathy including somnolence, confusion, or asterixis; History of myocardial infarction within 6 months or history of congestive heart failure (CHF); clinical evidence of CHF; Evidence of arrhythmia in patients with history of cardiac arrhythmia; Uncontrolled hypertension, unstable angina, active CHF, or serious uncontrolled cardiac arrhythmia; Interstitial pneumonia or fibroid lung (patients must have large pleural effusions drained and sclerosed or controlled prior to study; patients must have clinically apparent ascites drained prior to irinotecan treatment); CNS metastases or carcinomatous meningitis; Concurrent use of anticonvulsants; Active or uncontrolled

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00037804

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United States, Michigan
Research Center
Detroit, Michigan, United States, 48201
United States, New Jersey
Research Center
New Brunswick, New Jersey, United States, 08901
United States, Tennessee
Research Center
Nashville, Tennessee, United States, 37232
United States, Wisconsin
Research Center
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators

Layout table for additonal information Identifier: NCT00037804    
Obsolete Identifiers: NCT00002958
Other Study ID Numbers: M64750017
First Posted: May 22, 2002    Key Record Dates
Last Update Posted: August 14, 2009
Last Verified: August 2009
Keywords provided by Pfizer:
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents