Gallbladder Diseases |
Cholelithiasis; Gallbladder; Gallbladder Disease |
Clinical Trial: Liposomal Doxorubicin in Treating Patients With Liver or Bile Duct Cancer
This study is no longer recruiting patients.
|
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
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--
- Histologically confirmed carcinoma of the liver or bile ducts including hepatocellular carcinoma, cholangiocarcinoma, and gallbladder cancer
- Measurable or evaluable disease by CT scan (ascites, pleural effusions, and bone metastases are not considered evaluable)
--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
Howard Safran, Study Chair, Brown University
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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

Not Signed In -


