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Irinotecan and Flavopiridol in Treating Patients With Advanced Liver Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00087282
First Posted: July 12, 2004
Last Update Posted: June 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention Phase
Liver Cancer Drug: alvocidib Drug: irinotecan hydrochloride Phase 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Non-Randomized Phase II Study of Sequential Irinotecan (CPT-11) And Flavopiridol In Patients With Advanced Hepatoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2004
Study Completion Date: July 2006
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00087282


Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ghassan Abou-Alfa, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Gary K. Schwartz, MD Memorial Sloan Kettering Cancer Center
  More Information

ClinicalTrials.gov Identifier: NCT00087282     History of Changes
Other Study ID Numbers: CDR0000373877
MSKCC-04038
NCI-6475
First Submitted: July 8, 2004
First Posted: July 12, 2004
Last Update Posted: June 24, 2013
Last Verified: May 2005

Keywords provided by National Cancer Institute (NCI):
adult primary hepatocellular carcinoma
advanced adult primary liver cancer
recurrent adult primary liver cancer

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Irinotecan
Camptothecin
Alvocidib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Growth Inhibitors
Growth Substances
Physiological Effects of Drugs
Protein Kinase Inhibitors