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


Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Cancer, Metastatic Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to Progression

Outcome Description:

Time to progression was defined as time from embolization to documented disease progression. Patients without documented progression were censored at the time of the last documented disease evaluation or of the last treatment ended, whichever was more recent.Disease progression was defined as significant increase in size of lesions or appearance of new metastatic lesions. Specifically, 1) >=25% increase in the area of any malignant lesions greater than 2 cm² or in the sum of the products of the individual lesions in a given organ site; 2)>=50% increase in the size of the product of diameters if only one lesion is available for measurement and was less than or equal to 2 cm² in size at the initiation of therapy; 3)>=25% increase in the sum of the liver measurements below the costal margins and xyphoid; 4)Appearance of new malignant lesions

Outcome Time Frame:

Assessed every 3 months for 2 years, then every 6 months for 3 year.

Safety Issue:

No

Principal Investigator

Keith E. Stuart, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000067083

NCT ID:

NCT00003907

Start Date:

August 1999

Completion Date:

August 2012

Related Keywords:

  • Liver Cancer
  • Metastatic Cancer
  • localized unresectable adult primary liver cancer
  • advanced adult primary liver cancer
  • recurrent adult primary liver cancer
  • adult primary hepatocellular carcinoma
  • liver metastases
  • Liver Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Carcinoma, Hepatocellular

Name

Location

Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
St. Rita's Medical CenterLima, Ohio  45801
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Overlook HospitalSummit, New Jersey  07902-0220
Carol G. Simon Cancer Center at Morristown Memorial HospitalMorristown, New Jersey  07962
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Somerset Medical CenterSomerville, New Jersey  08876
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Front Range Cancer SpecialistsFort Collins, Colorado  80528
Hematology Oncology Associates - SkokieSkokie, Illinois  60076
Swedish Covenant HospitalChicago, Illinois  60625
Mercy Hospital and Medical CenterChicago, Illinois  60616
Hematology and Oncology AssociatesChicago, Illinois  60611
Midwest Center for Hematology/OncologyJoliet, Illinois  60432
North Shore Oncology and Hematology Associates, Limited - LibertyvilleLibertyville, Illinois  60048
Hematology/Oncology of the North Shore at Gross Point Medical CenterSkokie, Illinois  60076
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266