Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver Dysfunction (NCT00025415) | Clinical Trial Compass
CompletedPhase 1
Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver Dysfunction
United States60 participantsStarted 2001-08
Plain-language summary
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase I trial to study the effectiveness of imatinib mesylate in treating patients who have advanced cancer and liver dysfunction
Who can participate
Age range15 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically or cytologically confirmed surgically incurable solid tumor orhematologic malignancy for which no standard or palliative therapy exists oris no longer effective
* All tumor types are eligible, including:
* Chronic myelogenous leukemia or other Philadelphia chromosome-positive leukemia OR
* Gastrointestinal stromal tumors
* Patients with gliomas that require corticosteroids or anticonvulsants must beon a stable dose and seizure-free for 1 month
* No unstable or untreated (non-irradiated) brain metastases
* Performance status - ECOG 0-2
* Performance status - Karnofsky 60-100%
* More than 3 months
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* No active hemolysis
* See Surgery
* No evidence of biliary sepsis
* Creatinine normal
* Creatinine clearance at least 60 mL/min
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Able to swallow pills
* No other uncontrolled concurrent illness that would preclude study participation
* No ongoing or active infection
* No uncontrolled diarrhea
* No psychiatric illness or social situation that would preclude study compliance
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for 6 months after study completion
* At least 24 hours since prior colony-stimulating factors
* No concurrent colony-stimulating fac…
What they're measuring
1
MTD defined based on the toxicities observed during the first cycle of treatment
Timeframe: 4 weeks
2
Toxicity evaluation graded according to the NCI common toxicity criteria and relationship to the study drug