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Liposomal Doxorubicin in Treating Patients With Liver or Bile Duct Cancer - Article


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Gallbladder Cancer


Clinical Trial: Liposomal Doxorubicin in Treating Patients With Liver or Bile Duct Cancer

This study is no longer recruiting patients.

Sponsored by: Brown University
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients with liver or bile duct cancer.

Condition Treatment or Intervention Phase
recurrent adult primary liver cancer
localized gallbladder cancer
advanced adult primary liver cancer
cholangiocarcinoma of the gallbladder
localized resectable adult primary liver cancer
adult primary hepatocellular carcinoma
localized extrahepatic bile duct cancer
recurrent gallbladder cancer
unresectable gallbladder cancer
localized unresectable adult primary liver cancer
cholangiocarcinoma of the extrahepatic bile duct
adult primary cholangiocellular carcinoma
recurrent extrahepatic bile duct cancer
unresectable extrahepatic bile duct cancer
 Drug: doxorubicin HCl liposome
 Drug: filgrastim
Phase II

MedlinePlus related topics:  Bile Duct Diseases;   Cancer;   Cancer Alternative Therapy;   Digestive Diseases;   Gallbladder Diseases;   Liver Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Doxorubicin HCl Liposome in Patients with Hepatobiliary Carcinoma

Further Study Details: 

Study start: January 1998

OBJECTIVES: I. Determine the response rate and toxicity of doxorubicin HCl liposome in patients with carcinomas of the liver and bile ducts.

PROTOCOL OUTLINE: Patients receive doxorubicin HCl liposome IV over 15 minutes every 21 days. Filgrastim (G-CSF) is administered subcutaneously starting on day 2 and continuing for 10-14 days. Disease is restaged after every 3 courses. Treatment continues in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for the first year, and then every 6 months thereafter.

PROJECTED ACCRUAL: There will be 17-26 evaluable patients accrued into this study.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

  • Biologic therapy: Not specified
  • Chemotherapy: No prior doxorubicin; At least 4 weeks since prior chemotherapy
  • Endocrine therapy: Not specified
  • Radiotherapy: Prior radiotherapy allowed
  • Surgery: Not specified

--Patient Characteristics--

  • Age: 18 and over
  • Performance status: ECOG 0-2
  • Life expectancy: Not specified
  • Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3
  • Hepatic: Bilirubin less than 3 mg/dL; No severe cirrhosis
  • Renal: Creatinine no greater than 3.0 mg/dL
  • Cardiovascular: Left ventricular cardiac ejection fraction at least 45%
  • Other: No allergy to egg or egg products; Not pregnant or nursing; Effective contraception required of all fertile patients

Location Information


Massachusetts
      New England Medical Center Hospital, Boston,  Massachusetts,  02111,  United States

Rhode Island
      Brown University Oncology Group, Providence,  Rhode Island,  02912,  United States

Study chairs or principal investigators

Howard Safran,  Study Chair,  Brown University   

More Information

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

Study ID Numbers:  CDR0000066230; BRUOG-HB-71; NCI-V98-1408
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003296
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: October 3, 2005
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