Status:
COMPLETED
Irinotecan and Flavopiridol in Treating Patients With Advanced Liver Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan and flavopiridol, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill ...
Detailed Description
OBJECTIVES: Primary * Determine the time to progression in patients with advanced hepatocellular carcinoma treated with irinotecan and flavopiridol. Secondary * Determine the response rate and ove...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed hepatocellular carcinoma
- Advanced disease
- Measurable disease
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- Prior local therapy (e.g., surgery, hepatic arterial embolization, radiofrequency ablation, or cryoablation) allowed provided therapy was completed ≥ 8 weeks before study entry AND ≥ 1 of the following conditions are met:
- Target lesion was not subjected to local therapy
- 25% increase in the size of target lesion within the field of prior local therapy
- Lesions treated with external beam radiotherapy are not acceptable as target lesions
- Child-Pugh class A or B status if liver cirrhosis is present
- Score 7 or 8 only
- No known brain metastases
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Karnofsky 70-100%
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 75,000/mm\^3
- WBC ≥ 3,000/mm\^3
- Hepatic
- See Disease Characteristics
- AST and ALT ≤ 2.5 times upper limit of normal
- Bilirubin ≤ 1.5 mg/dL
- Renal
- Creatinine normal OR
- Creatinine clearance ≥ 60 mL/min
- Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No deep vein thrombosis within the past 6 months
- Patients maintained on anticoagulation therapy for an event that occurred more than 6 months ago are eligible
- No myocardial infarction within the past 6 months
- No cardiac arrhythmia within the past 6 months
- Rate-controlled atrial fibrillation allowed if stable for at least 6 months
- Pulmonary
- No pulmonary embolus within the past 6 months
- Patients maintained on anticoagulation therapy for an event that occurred more than 6 months ago are eligible
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
- No prior allergic reaction attributed to compounds of similar chemical or biological composition to flavopiridol or irinotecan
- No clinically significant gastrointestinal bleeding requiring hospitalization within the past month
- No active or ongoing infection
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
- No other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell skin cancer, or superficial bladder tumors \[Ta, Tis, or T1\]
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior systemic biologic therapy
- Chemotherapy
- No prior systemic chemotherapy for hepatocellular carcinoma
- No other concurrent chemotherapy
- Endocrine therapy
- Not specified
- Radiotherapy
- See Disease Characteristics
- Surgery
- See Disease Characteristics
- No prior organ allograft
- Other
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No concurrent vitamins, antioxidants, or herbal preparations and supplements
- Single-tablet multivitamin allowed
- No other concurrent investigational agents
- No other concurrent anticancer agents or therapies
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00087282
Start Date
June 1 2004
End Date
July 1 2006
Last Update
June 24 2013
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021