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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003907 |
RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor.
PURPOSE: Phase II trial to study the effectiveness of chemoembolization in treating patients who have primary liver cancer or metastases to the liver that cannot be surgically removed.
Condition | Intervention | Phase |
---|---|---|
Liver Cancer Metastatic Cancer |
Drug: cisplatin Drug: doxorubicin hydrochloride Drug: mitomycin C Procedure: embolization therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Chemoembolization in Hepatocellular Carcinoma or Neuroendocrine Hepatic Metastases: A Phase II Multi-Center Trial |
Estimated Enrollment: | 42 |
Study Start Date: | August 1999 |
OBJECTIVES:
OUTLINE: Patients are stratified according to disease (hepatocellular carcinoma vs neuroendocrine hepatic metastases).
Patients undergo placement of a visceral arterial catheter. Patients receive doxorubicin, mitomycin, and cisplatin as a chemoemulsion via the arterial catheter into 1 hepatic lobe only. Immediately following delivery of the chemoemulsion, particulate embolization is performed. The opposite lobe, if involved, is treated within 3-5 weeks of treatment of the initial lobe.
In the absence of unacceptable toxicity, each involved lobe is treated separately a second time, in the same sequence, beginning 8 weeks after the last lobular chemoembolization. After completion of all protocol therapy, retreatment on study of either lobe is allowed for regrowth, recurrence, or new disease, provided at least 3 months have elapsed since the initial treatment of that lobe.
Patients are followed for 5 years.
PROJECTED ACCRUAL: A total of 19-42 patients will be accrued for this study within 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Biopsy proven intrahepatic hepatocellular carcinoma or neuroendocrine hepatic metastases that are deemed unresectable
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Study Chair: | Keith E. Stuart, MD | Beth Israel Deaconess Medical Center |
Study ID Numbers: | CDR0000067083, ECOG-4298 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003907 |
Health Authority: | United States: Federal Government |
localized unresectable adult primary liver cancer advanced adult primary liver cancer recurrent adult primary liver cancer adult primary hepatocellular carcinoma liver metastases |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms Mitomycins Doxorubicin Recurrence Carcinoma Liver Neoplasms |
Digestive System Diseases Cisplatin Mitomycin Neoplasm Metastasis Gastrointestinal Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial Hepatocellular carcinoma |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Antibiotics, Antineoplastic Pharmacologic Actions Neoplasms |
Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses Alkylating Agents Nucleic Acid Synthesis Inhibitors |