Irinotecan and Flavopiridol in Treating Patients With Advanced Liver Cancer

NCT ID: NCT00087282

Last Updated: 2013-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2006-07-31

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.

Conditions

Liver Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

alvocidib

Intervention Type: DRUG

irinotecan hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Ghassan Abou-Alfa, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Gary K. Schwartz, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

MSKCC-04038

Identifier Type: -

Identifier Source: secondary_id

NCI-6475

Identifier Type: -

Identifier Source: secondary_id

CDR0000373877

Identifier Type: -

Identifier Source: org_study_id