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Thalidomide and Chemoembolization With Doxorubicin in Treating Patients With Liver Cancer That Cannot be Removed by Surgery
This study has been completed.
First Received: July 5, 2000   Last Updated: July 23, 2008   History of Changes
Sponsor: New York University School of Medicine
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006016
  Purpose

RATIONALE: Thalidomide may stop the growth of liver cancer by stopping blood flow to the tumor. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Combining thalidomide with chemoembolization may kill more tumor cells.

PURPOSE: This phase II trial is studying the effectiveness of combining thalidomide and chemoembolization in treating patients who have liver cancer that cannot be removed by surgery.


Condition Intervention Phase
Liver Cancer
Drug: doxorubicin hydrochloride
Drug: thalidomide
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: An Evaluation of Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular Cancer

Resource links provided by NLM:


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

Study Start Date: September 2000
Detailed Description:

OBJECTIVES:

  • Determine the feasibility and potential activity of thalidomide in patients with unresectable hepatocellular carcinoma who are undergoing chemoembolization to predominant tumor masses.
  • Determine the toxicity of this regimen of these patients.
  • Determine the overall survival of patients treated with this regimen.
  • Determine the serum levels of vascular endothelial growth factor, basic fibroblast growth factor, and tumor necrosis factor alpha in patients treated with this regimen.

OUTLINE: Patients receive oral thalidomide daily beginning 4 weeks before the first planned chemoembolization procedure. Thalidomide administration is stopped 24 hours before each chemoembolization procedure, and then restarted at 24 hours after completion of each procedure OR when blood counts and levels of bilirubin and transaminases recover, whichever occurs later. Thalidomide treatment continues in the absence of disease progression or unacceptable toxicity.

Patients undergo placement of a visceral arterial catheter. Patients receive doxorubicin as a chemoemulsion via the arterial catheter into 1 hepatic lobe only under angiographic guidance. Immediately after delivery of the chemoemulsion, patients undergo particulate embolization. The opposite lobe, if involved, is treated within 3-5 weeks of treatment of the initial lobe. Patients are reevaluated for repeat chemoembolization within 8-12 weeks of the last chemoembolization. For eligible patients, each lobe is treated separately a second time, in the same sequence, in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 18 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven hepatocellular carcinoma
  • Ineligible for potentially curative surgical resection
  • Must be a candidate for palliative chemoembolization

    • MRI must show one or more discrete tumor nodules that can be targeted by angiography for chemoembolization

      • No diffusely infiltrating tumor
    • Lesions under consideration for chemoembolization must demonstrate substantial hypervascularity

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,200/mm^3
  • Hemoglobin at least 8.0 g/dL
  • Platelet count at least 50,000/mm^3

Hepatic:

  • SGOT and SGPT no greater than 5 times normal
  • Bilirubin less than 3 mg/dL

Renal:

  • Creatinine no greater than 1.5 mg/dL

Other:

  • No other medical condition that would preclude study participation
  • No other malignancy within the past 5 years except curatively resected basal cell skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test
  • Regardless of fertility status:

    • All female patients (unless they have undergone a hysterectomy or have been amenorrheic or postmenopausal for at least 2 years) must use at least 1 highly active method of contraception AND 1 additional effective method of contraception at least 4 weeks before, during, and for at least 4 weeks after study participation
    • All male patients (even if they have undergone a successful vasectomy) must use effective barrier contraception during and for at least 4 weeks after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Prior interferon for hepatitis allowed
  • No prior biologic therapy for hepatocellular carcinoma (HCC)

Chemotherapy:

  • No prior chemotherapy for hepatocellular carcinoma (HCC)

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics

Other:

  • No concurrent barbiturates or alcohol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006016

Locations
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Mount Sinai School of Medicine
New York, New York, United States, 10029
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Study Chair: Alec S. Goldenberg, MD New York University School of Medicine
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068025, NYU-9937, NCI-99
Study First Received: July 5, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00006016     History of Changes
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Anti-Infective Agents
Liver Diseases
Digestive System Neoplasms
Immunologic Factors
Thalidomide
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Angiogenesis Inhibitors
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Liver Neoplasms
Anti-Bacterial Agents
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on November 11, 2009