Chemoembolization in Treating Patients With Primary Liver Cancer or Metastases to the Liver - Full Text View

Sponsors and Collaborators:	Eastern Cooperative Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003907

Purpose

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: embolization therapy Drug: mitomycin C	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: Mitomycin Cisplatin Doxorubicin Doxorubicin hydrochloride Myocet Mitomycins

U.S. FDA Resources

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

Primary Outcome Measures:

Time to progression [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tumor response [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Survival [ Designated as safety issue: No ]
Extrahepatic patterns of failure [ Designated as safety issue: No ]
Chemoembolization [ Designated as safety issue: No ]

Estimated Enrollment:	42
Study Start Date:	August 1999

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

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

Criteria

DISEASE CHARACTERISTICS:

Biopsy proven intrahepatic hepatocellular carcinoma or neuroendocrine hepatic metastases that are deemed unresectable
- Biopsy may be waived if there is known clinical cirrhosis or chronic hepatitis and alphafetoprotein greater than 500 ng/mL
Bidimensionally measurable disease
Evidence of patent portal vasculature by Doppler ultrasound, MRI, or angiography
No evidence of extrahepatic disease that is likely to be life threatening within 3 months (e.g., brain or symptomatic lung metastases)

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

At least 3 months

Hematopoietic

Absolute neutrophil count greater than 2,000/mm^3
Platelet count greater than 50,000/mm^3

Hepatic

Bilirubin less than 2.0 mg/dL

Renal

Creatinine less than 2.0 mg/dL

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for at least 2 months after study participation
No concurrent active malignancy
No history of life-threatening contrast allergy

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior intraarterial or intrahepatic chemotherapy
At least 4 weeks since prior systemic chemotherapy

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003907

Show 37 Study Locations

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Keith E. Stuart, MD

Beth Israel Deaconess Medical Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000067083, ECOG-4298
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003907 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
recurrent adult primary liver cancer
adult primary hepatocellular carcinoma
liver metastases

Study placed in the following topic categories:

Liver Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Mitomycins
Recurrence
Doxorubicin
Carcinoma
Liver Neoplasms
Anti-Bacterial Agents

Digestive System Diseases
Cisplatin
Mitomycin
Neoplasm Metastasis
Gastrointestinal Neoplasms
Adenocarcinoma
Hepatocellular Carcinoma
Alkylating Agents
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Liver Diseases
Neoplasms by Histologic Type
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Carcinoma, Hepatocellular
Enzyme Inhibitors
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin
Carcinoma
Liver Neoplasms

Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Mitomycin
Neoplasm Metastasis
Adenocarcinoma
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 02, 2009