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Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Chemotherapy, Liver Dysfunction, Neoplasms, Solid Tumor

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Trial Information

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

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

Type of Study:


Study Design:

Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor
  • Chemotherapy
  • Liver Dysfunction
  • Neoplasms, Solid Tumor
  • Pharmacia
  • Neoplasms
  • Liver Diseases



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