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Irinotecan and Flavopiridol in Treating Patients With Advanced Liver Cancer

Primary Purpose

Liver Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
alvocidib
irinotecan hydrochloride
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring adult primary hepatocellular carcinoma, advanced adult primary liver cancer, recurrent adult primary liver cancer

Eligibility Criteria

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

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 8, 2004
Last Updated
June 21, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00087282
Brief Title
Irinotecan and Flavopiridol in Treating Patients With Advanced Liver Cancer
Official Title
A Non-Randomized Phase II Study of Sequential Irinotecan (CPT-11) And Flavopiridol In Patients With Advanced Hepatoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2005
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
adult primary hepatocellular carcinoma, advanced adult primary liver cancer, recurrent adult primary liver cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
alvocidib
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghassan Abou-Alfa, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gary K. Schwartz, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Irinotecan and Flavopiridol in Treating Patients With Advanced Liver Cancer

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