Brief Title
Doxorubicin Hydrochloride Liposome and Carboplatin in Treating Patients With Recurrent, Stage III, or Stage IV Primary Endometrial Cancer
Official Title
A Multi-center Phase II Study of Doxil®/Carboplatin in Patients With Advanced or Recurrent Endometrial Carcinoma
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 them from dividing. Giving more than one drug (combination chemotherapy)
may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride liposome
together with carboplatin works in treating patients with recurrent, stage III, or stage IV
primary endometrial cancer.
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.
Secondary
- Determine progression-free survival of patients treated with this regimen.
- Determine overall survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin
IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 8 courses in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 6 months and then every 3
months thereafter.
PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Response (Complete and Partial)
Condition
Endometrial Cancer
Intervention
carboplatin
Study Arms / Comparison Groups
Doxorubicin and carboplatin
Description: Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
9
Start Date
February 2007
Completion Date
December 2009
Primary Completion Date
May 2008
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Shashikant B. Lele, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00470067
Organization ID
CDR0000543389
Secondary IDs
RPCI-I-68005
Responsible Party
Sponsor
Study Sponsor
Roswell Park Cancer Institute
Study Sponsor
Shashikant B. Lele, MD, Principal Investigator, Roswell Park Cancer Institute
Verification Date
August 2014