search
Back to results

Irinotecan in Treating Patients With Refractory Solid Tumors and Liver Dysfunction

Primary Purpose

Unspecified Adult Solid Tumor, Chemotherapy, Liver Dysfunction

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Irinotecan
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unspecified Adult Solid Tumor focused on measuring Pharmacia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Center
  • Research Center
  • Research Center
  • Research Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 21, 2002
Last Updated
August 13, 2009
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00037804
Brief Title
Irinotecan in Treating Patients With Refractory Solid Tumors and Liver Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unspecified Adult Solid Tumor, Chemotherapy, Liver Dysfunction, Neoplasms, Solid Tumor
Keywords
Pharmacia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Irinotecan

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Research Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Research Center
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Research Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Irinotecan in Treating Patients With Refractory Solid Tumors and Liver Dysfunction

We'll reach out to this number within 24 hrs