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Chemoembolization in Hepatocellular Carcinoma or Neuroendocrine Hepatic Metastases: A Phase II Multi-Center Trial (NCT00003907)

National Cancer Institute (NCI)
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.
  • Drug: cisplatin
    Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).
    • Cis-diaminedichloroplatinum Cis-diaminedichloroplatinum (II),
    • diaminedichloroplatinum,
    • cis-platinum,
    • platinum,
    • Platinol,
    • Platinol-AQ,
    • DDP,
    • CDDP,
    • DACP,
    • NSC 119875
  • Drug: doxorubicin
    Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).
    • Adriamycin,
    • Rubex,
    • Adriamycin RDF,
    • Adriamycin PFS,
    • hydroxydaunorubicin,
    • hydroxydaunomycin,
    • ADR
  • Drug: mitomycin
    Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).
    • Mutamycin,
  • Procedure: embolization
    Immediately following delivery of the chemoemulsion, particulate embolization is performed. The particulate embolic material is prepared on a separate table or tray, using absorbable gelatin sponge (Gelfoam, Upjohn, Kalamazoo, MI), in either powder or pledget form. Approximately 1 g of this temporary occlusive agent is dissolved in 20-30 cc of full-strength contrast with 2.4 cc of absolute alcohol.
    • trans-arterial chemoembolization,
    • TACE
Ages eligible for Study
18 Years and older
Genders eligible for Study
All
Accepts Healthy Volunteers
No
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.
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.

37 locations

United States (37)
  • Front Range Cancer Specialists
    Not specified
    Fort Collins, Colorado, United States, 80524
  • Baptist Cancer Institute - Jacksonville
    Not specified
    Jacksonville, Florida, United States, 32207
  • Winship Cancer Institute of Emory University
    Not specified
    Altanta, Georgia, United States, 30322
  • Veterans Affairs Medical Center - Atlanta (Decatur)
    Not specified
    Decatur, Georgia, United States, 30033
  • Rush-Copley Cancer Care Center
    Not specified
    Aurora, Illinois, United States, 60507
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
    Not specified
    Chicago, Illinois, United States, 60611-3013
  • Hematology and Oncology Associates
    Not specified
    Chicago, Illinois, United States, 60611
  • Veterans Affairs Medical Center - Lakeside Chicago
    Not specified
    Chicago, Illinois, United States, 60611
  • Mercy Hospital and Medical Center
    Not specified
    Chicago, Illinois, United States, 60616
  • Swedish Covenant Hospital
    Not specified
    Chicago, Illinois, United States, 60625
  • Hinsdale Hematology Oncology Associates
    Not specified
    Hinsdale, Illinois, United States, 60521
  • Midwest Center for Hematology/Oncology
    Not specified
    Joliet, Illinois, United States, 60432
  • Joliet Oncology-Hematology Associates, Limited - West
    Not specified
    Joliet, Illinois, United States, 60435
  • North Shore Oncology and Hematology Associates, Limited - Libertyville
    Not specified
    Libertyville, Illinois, United States, 60048
  • Hematology Oncology Associates - Skokie
    Not specified
    Skokie, Illinois, United States, 60076
  • Hematology/Oncology of the North Shore at Gross Point Medical Center
    Not specified
    Skokie, Illinois, United States, 60076
  • Carle Cancer Center at Carle Foundation Hospital
    Not specified
    Urbana, Illinois, United States, 61801
  • CCOP - Carle Cancer Center
    Not specified
    Urbana, Illinois, United States, 61801
  • Saint Anthony Memorial Health Centers
    Not specified
    Michigan City, Indiana, United States, 46360
  • Mercy Capitol Hospital
    Not specified
    Des Moines, Iowa, United States, 50307
  • CCOP - Iowa Oncology Research Association
    Not specified
    Des Moines, Iowa, United States, 50309
  • John Stoddard Cancer Center at Iowa Methodist Medical Center
    Not specified
    Des Moines, Iowa, United States, 50309
  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
    Not specified
    Des Moines, Iowa, United States, 50309
  • Medical Oncology and Hematology Associates at Mercy Cancer Center
    Not specified
    Des Moines, Iowa, United States, 50314
  • Mercy Cancer Center at Mercy Medical Center - Des Moines
    Not specified
    Des Moines, Iowa, United States, 50314
  • John Stoddard Cancer Center at Iowa Lutheran Hospital
    Not specified
    Des Moines, Iowa, United States, 50316-2301
  • Medical Oncology and Hematology Associates - West Des Moines
    Not specified
    West Des Moines, Iowa, United States, 50266
  • Borgess Medical Center
    Not specified
    Kalamazooaa, Michigan, United States, 49001
  • West Michigan Cancer Center
    Not specified
    Kalamazoo, Michigan, United States, 49007-3731
  • Bronson Methodist Hospital
    Not specified
    Kalamazoo, Michigan, United States, 49007
  • Carol G. Simon Cancer Center at Morristown Memorial Hospital
    Not specified
    Morristown, New Jersey, United States, 07962
  • Somerset Medical Center
    Not specified
    Somerville, New Jersey, United States, 08876
  • Overlook Hospital
    Not specified
    Summit, New Jersey, United States, 07902
  • Case Comprehensive Cancer Center
    Not specified
    Cleveland, Ohio, United States, 44106
  • St. Rita's Medical Center
    Not specified
    Lima, Ohio, United States, 45801
  • Fox Chase Cancer Center - Philadelphia
    Not specified
    Philadelphia, Pennsylvania, United States, 19111-2497
  • Albert Einstein Cancer Center
    Not specified
    Philadelphia, Pennsylvania, United States, 19141
Participant Flow: Overall Study
Hepatocellular Carcinoma
Neuroendocrine Hepatic Metastases
Serious Adverse Events
Hepatocellular Carcinoma
Neuroendocrine Hepatic Metastases
Other Adverse Events
Hepatocellular Carcinoma
Neuroendocrine Hepatic Metastases
Status:
completed
Type:
Interventional
Phase:
Start:
31 July, 1999
Updated:
11 February, 2013
Participants:
50
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