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Irinotecan in Treating Patients With Refractory Solid Tumors and Liver Dysfunction

Last updated on November 16, 2019

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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Descriptive Information
Brief Title  ICMJE Irinotecan in Treating Patients With Refractory Solid Tumors and Liver Dysfunction
Official Title  ICMJE Not Provided
Brief SummaryDrugs 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Unspecified Adult Solid Tumor
  • Chemotherapy
  • Liver Dysfunction
  • Neoplasms, Solid Tumor
Intervention  ICMJE Drug: Irinotecan
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00037804
Other Study ID Numbers  ICMJE M64750017
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS AccountPfizer
Verification DateAugust 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now