Liposomal Doxorubicin in Treating Patients With Advanced Stomach Cancer
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|ClinicalTrials.gov Identifier: NCT00004236|
Recruitment Status : Unknown
Verified December 2000 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : June 9, 2004
Last Update Posted : June 24, 2014
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 who have advanced stomach cancer.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Gastric Cancer||Drug: pegylated liposomal doxorubicin hydrochloride||Phase 2|
OBJECTIVES: I. Determine overall survival, time to disease progression, objective reponse rate, safety profile, and quality of life in patients with inoperable gastric adenocarcinoma when treated with doxorubicin HCl liposome.
OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour every 4 weeks. Treatment continues for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients with responding disease may continue therapy past the 6 courses until documented disease progression. Quality of life is assessed prior to every treatment course. All patients are followed at 1 month. Patients with stable or responding disease are then followed every 3 months until death.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 24 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Study of Caelyx in the Treatment of Advanced Gastric Cancer|
|Study Start Date :||August 1998|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004236
|University Hospitals of Leicester|
|Leicester, England, United Kingdom, LE1 5WW|
|Study Chair:||Kenneth O'Byrne, MD||University Hospitals, Leicester|