Doxorubicin Hydrochloride Liposome and Carboplatin in Treating Patients With Recurrent, Stage III, or Stage IV Primary Endometrial Cancer
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Intervention: carboplatin; pegylated liposomal doxorubicin hydrochloride
Intervention description: IV; IV
Intervention MeSH terms: Carboplatin; Doxorubicin; Liposomal doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent endometrial carcinoma; stage III endometrial carcinoma; stage IV endometrial carcinoma

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.
    

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