Status:
TERMINATED
Doxorubicin Hydrochloride Liposome and Carboplatin in Treating Patients With Recurrent, Stage III, or Stage IV Primary Endometrial Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping ...
Detailed Description
OBJECTIVES: Primary * Estimate the response rate in patients with recurrent or stage III or IV primary endometrial carcinoma treated with doxorubicin hydrochloride liposome and carboplatin. Seconda...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed primary endometrial carcinoma meeting 1 of the following criteria:
- Stage III or IV disease according to FIGO staging criteria
- Recurrent disease that is considered incurable
- Measurable disease
- A lesion within a previously irradiated field is acceptable as measurable disease only if there has been clear progression since completion of radiotherapy
- PATIENT CHARACTERISTICS:
- GOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL
- Creatinine \< 2.5 mg/dL OR creatinine clearance ≥ 60 mL/min
- ALT and AST ≤ 1.5 times upper limit of normal (ULN) (3 times ULN in the presence of liver metastases)
- Alkaline phosphatase ≤ 1.5 times ULN (3 times ULN in the presence of liver metastases)
- Total bilirubin ≤ 1.5 times ULN (3 times ULN in the presence of liver metastases)
- Not pregnant or nursing
- Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA scan or ECHO
- No history of severe hypersensitivity reaction to doxorubicin hydrochloride liposome
- No other invasive malignancy (i.e., breast cancer) within the past 5 years except nonmelanoma skin cancer
- No cardiac disease, including any of the following:
- Myocardial infarction within the past 6 months
- NYHA class II-IV heart failure
- Uncontrolled angina
- Severe uncontrolled ventricular arrhythmias
- Clinically significant pericardial disease
- Acute ischemic or active conduction system abnormalities by ECHO
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy
- No prior cancer therapy that would contraindicate study treatment
- No concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00470067
Start Date
February 1 2007
End Date
December 1 2009
Last Update
August 22 2014
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001