You are here

Irinotecan in Treating Patients With Refractory Solid Tumors and Liver Dysfunction

Last updated on February 22, 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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Chemotherapy-Induced Peripheral Neuropathy
NCT00380874
All Genders
18+
Years
Multiple Sites
Unspecified Adult Solid Tumor, Chemotherapy, Liver Dysfunction, Solid Tumor Neoplasms
NCT00037804
All Genders
18+
Years
Multiple Sites
Chemotherapy-Induced Neutropenia
NCT02454530
All Genders
18+
Years
Multiple Sites
Diabetic Peripheral Neuropathic Pain (DPN), Postherpetic Neuralgia (PHN), HIV-related Neuropathic Pain (HIV), Chemotherapy Induced Neuropathic Pain
NCT00407511
All Genders
18+
Years
Multiple Sites

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