Completed

Irinotecan and Flavopiridol in Treating Patients With Advanced Liver Cancer

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What is being tested

alvocidib

+ irinotecan hydrochloride
Drug
Who is being recruted

Liver Cancer

Over 18 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 2004

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: June 24, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2004Actual date on which the first participant was enrolled.

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. OBJECTIVES: Primary * Determine the time to progression in patients with advanced hepatocellular carcinoma treated with irinotecan and flavopiridol. Secondary * Determine the response rate and overall survival in patients treated with this regimen. * Determine the toxicity of this regimen in these patients. OUTLINE: This is an open-label, non-randomized study. Patients receive irinotecan IV over 30 minutes and flavopiridol IV over 1 hour on days 1, 8, 15, and 22. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 16-32 patients will be accrued for this study within 2 years.

Official TitleA Non-Randomized Phase II Study of Sequential Irinotecan (CPT-11) And Flavopiridol In Patients With Advanced Hepatoma 
Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: June 24, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Liver Cancer
Criteria

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



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Memorial Sloan-Kettering Cancer CenterNew York, United StatesSee the location

CompletedOne Study Center