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Chemoembolization in Treating Patients With Primary Liver Cancer or Metastases to the Liver

Information source: Eastern Cooperative Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Liver Cancer; Metastatic Cancer

Intervention: cisplatin (Drug); doxorubicin (Drug); mitomycin (Drug); embolization (Procedure)

Phase: Phase 2

Status: Completed

Sponsored by: Eastern Cooperative Oncology Group

Official(s) and/or principal investigator(s):
Keith E. Stuart, MD, Study Chair, Affiliation: Beth Israel Deaconess Medical Center

Summary

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.

Clinical Details

Official title: Chemoembolization in Hepatocellular Carcinoma or Neuroendocrine Hepatic Metastases: A Phase II Multi-Center Trial

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time to Progression

Secondary outcome:

Tumor Response

Overall Survival

Detailed description: OBJECTIVES:

- Evaluate time to progression of disease in patients with unresectable hepatocellular

carcinoma or neuroendocrine hepatic metastases undergoing chemoembolization.

- Evaluate tumor response achievable with chemoembolization in this patient population.

- Evaluate the toxicities of this treatment in these patients.

- Evaluate survival of these patients following this treatment.

- Evaluate extrahepatic patterns of failure following chemoembolization, to determine

whether intrahepatic progression may be forestalled and survival affected in these patients.

- Validate a consistent method of performing chemoembolization in a multicenter setting.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Biopsy-proven intrahepatic hepatocellular carcinoma or neuroendocrine tumor.

- Unresectable.

- Bidimensionally measurable disease by Computed Tomography (CT), Magnetic resonance

imaging (MRI), or UltraSound Scanning (US) within 6 weeks of registration.

- Evidence of patent portal vasculature by Doppler US, MRI, or angiography.

- Serum total bilirubin < 2. 0 mg/dl and serum creatinine < 2. 0 mg/dl within 4 weeks of

registration.

- Absolute neutrophil count (ANC) > 2000/µl and platelets > 50,000/µl within 4 weeks of

registration.

- Expected survival of at least 3 months.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Age >= 18 years.

Exclusion Criteria:

- Evidence of extrahepatic disease that is likely to be life-threatening within 3

months, such as brain or symptomatic lung metastases.

- Previous intra-arterial or intra-hepatic chemotherapy or prior systemic chemotherapy

within 4 weeks.

- Concurrent malignancy.

- Pregnant or breast-feeding women.

- History of life-threatening contrast allergy.

Locations and Contacts

Front Range Cancer Specialists, Fort Collins, Colorado 80524, United States

Baptist Cancer Institute - Jacksonville, Jacksonville, Florida 32207, United States

Winship Cancer Institute of Emory University, Altanta, Georgia 30322, United States

Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia 30033, United States

Rush-Copley Cancer Care Center, Aurora, Illinois 60507, United States

Hematology and Oncology Associates, Chicago, Illinois 60611, United States

Mercy Hospital and Medical Center, Chicago, Illinois 60616, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois 60611-3013, United States

Swedish Covenant Hospital, Chicago, Illinois 60625, United States

Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois 60611, United States

Hinsdale Hematology Oncology Associates, Hinsdale, Illinois 60521, United States

Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois 60435, United States

Midwest Center for Hematology/Oncology, Joliet, Illinois 60432, United States

North Shore Oncology and Hematology Associates, Limited - Libertyville, Libertyville, Illinois 60048, United States

Hematology Oncology Associates - Skokie, Skokie, Illinois 60076, United States

Hematology/Oncology of the North Shore at Gross Point Medical Center, Skokie, Illinois 60076, United States

Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois 61801, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

Saint Anthony Memorial Health Centers, Michigan City, Indiana 46360, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309, United States

John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa 50316-2301, United States

John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa 50309, United States

Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines, Iowa 50309, United States

Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines, Iowa 50314, United States

Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa 50314, United States

Mercy Capitol Hospital, Des Moines, Iowa 50307, United States

Medical Oncology and Hematology Associates - West Des Moines, West Des Moines, Iowa 50266, United States

Borgess Medical Center, Kalamazooaa, Michigan 49001, United States

Bronson Methodist Hospital, Kalamazoo, Michigan 49007, United States

West Michigan Cancer Center, Kalamazoo, Michigan 49007-3731, United States

Carol G. Simon Cancer Center at Morristown Memorial Hospital, Morristown, New Jersey 07962, United States

Somerset Medical Center, Somerville, New Jersey 08876, United States

Overlook Hospital, Summit, New Jersey 07902, United States

Case Comprehensive Cancer Center, Cleveland, Ohio 44106, United States

St. Rita's Medical Center, Lima, Ohio 45801, United States

Albert Einstein Cancer Center, Philadelphia, Pennsylvania 19141, United States

Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania 19111-2497, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: August 1999
Last updated: February 12, 2013

Page last updated: August 23, 2015

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