Trials / Completed
CompletedNCT00005861
Liposomal Doxorubicin in Treating Patients With Advanced or Recurrent Endometrial Cancer
Evaluation of Doxil as First-Line Therapy of Advanced or Recurrent Endometrial Carcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Gynecologic Oncology Group · Network
- Sex
- Female
- Age
- —
- 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 women who have recurrent, stage III, or stage IV endometrial cancer.
Detailed description
OBJECTIVES: * Determine the antitumor activity and safety of doxorubicin HCl liposome in patients with advanced or recurrent endometrial cancer. * Determine the response rate, response duration, and overall survival of these patients treated with this regimen. OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pegylated liposomal doxorubicin hydrochloride |
Timeline
- Start date
- 2000-05-01
- Primary completion
- 2005-08-01
- First posted
- 2003-05-19
- Last updated
- 2013-06-10
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00005861. Inclusion in this directory is not an endorsement.