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Irinotecan in Treating Patients With Refractory Solid Tumors and Liver Dysfunction

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Research Center
Detroit, Michigan, 48201 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Unspecified Adult Solid Tumor, Chemotherapy, Liver Dysfunction, Solid Tumor Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

further examination by the investigator is necessary.

NCT00037804
Pfizer
Completed
Irinotecan in Treating Patients With Refractory Solid Tumors and Liver Dysfunction

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Irinotecan in Treating Patients With Refractory Solid Tumors and Liver Dysfunction
Not Provided
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.
Not Provided
Interventional
Phase 1
Primary Purpose: Treatment
  • Unspecified Adult Solid Tumor
  • Chemotherapy
  • Liver Dysfunction
  • Neoplasms, Solid Tumor
Drug: Irinotecan
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00037804
M64750017
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Not Provided
Pfizer
August 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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