Clinical trial · Interventional
Irinotecan and Flavopiridol in Treating Patients With Advanced Liver Cancer
A Non-Randomized Phase II Study of Sequential Irinotecan (CPT-11) And Flavopiridol In Patients With Advanced Hepatoma
NCT00087282CI-TRIAL-00010953completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 more tumor cells. PURPOSE: This phase II trial is studying how well giving irinotecan together with flavopiridol works in treating patients with advanced liver cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alvocidib | Drug | Alvocidib | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 therapiesReferences
Publications (0)
Data not yet available
No reference posted for this study.