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Epirubicin and Thalidomide in Treating Patients With Liver Cancer

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Liver Cancer

Intervention: epirubicin hydrochloride (Drug); thalidomide (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Dana-Farber Cancer Institute

Official(s) and/or principal investigator(s):
Andrew X. Zhu, MD, PhD, Study Chair, Affiliation: Dana-Farber Cancer Institute

Summary

RATIONALE: Drugs used in chemotherapy such as epirubicin use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of hepatocellular (liver) cancer by stopping blood flow to the tumor. Combining epirubicin with thalidomide may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining epirubicin with thalidomide in treating patients who have unresectable or metastatic liver cancer.

Clinical Details

Official title: A Phase II Study Of Epirubicin And Thalidomide In Unresectable Or Metastatic Hepatocellular Carcinoma

Study design: Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Antitumor activity

Toxic effects

Detailed description: OBJECTIVES:

- Determine the antitumor activity of epirubicin and thalidomide in patients with locally

unresectable or metastatic hepatocellular carcinoma.

- Determine the toxic effects of this regimen in these patients.

OUTLINE: Patients receive epirubicin on days 1, 8, and 15 and thalidomide on days 1-21. Courses repeat every 28 days. PROJECTED ACCRUAL: A total of 12 patients per year will be accrued for this study.

Eligibility

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

Criteria:

DISEASE CHARACTERISTICS:

- Diagnosis of hepatocellular carcinoma

- Locally unresectable or metastatic disease

- Measurable disease

- No clinically apparent CNS metastases

- No carcinomatous meningitis

PATIENT CHARACTERISTICS: Age

- Over 18

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 75,000/mm^3

Hepatic

- SGOT no greater than 5 times upper limit of normal

- Bilirubin no greater than 3. 0 mg/dL

- INR no greater than 1. 5*

- Albumin at least 2. 0 g/dL NOTE: *Not required for patients receiving full

anticoagulation with warfarin for deep vein thrombosis or pulmonary embolism Renal

- Creatinine no greater than 2. 0 mg/dL

Cardiovascular

- No myocardial infarction within the past 6 months

- LVEF normal by echocardiogram or MUGA

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Willing and able to participate in the System for Thalidomide Education and

Prescribing Safety (STEPS) program

- No uncontrolled serious medical or psychiatric illness

- No other concurrent uncontrolled malignancy

PRIOR CONCURRENT THERAPY: Biologic therapy

- Not specified

Chemotherapy

- No more than 1 prior chemotherapy regimen for hepatocellular carcinoma

- No prior chemoembolization to the liver

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- More than 2 weeks since prior major surgery

Locations and Contacts

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States

Massachusetts General Hospital Cancer Center, Boston, Massachusetts 02114, United States

Additional Information

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

Starting date: December 2001
Last updated: July 17, 2013

Page last updated: August 23, 2015

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