Trials / Unknown
UnknownNCT00004236
Liposomal Doxorubicin in Treating Patients With Advanced Stomach Cancer
A Phase II Study of Caelyx in the Treatment of Advanced Gastric Cancer
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- University of Leicester · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pegylated liposomal doxorubicin hydrochloride |
Timeline
- Start date
- 1998-08-01
- First posted
- 2004-06-09
- Last updated
- 2014-06-24
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT00004236. Inclusion in this directory is not an endorsement.