Clinical trial NCT00052312 (phase 2, status: completed)
Conditions: endometrial cancer
ICD codes: N85.00, N85.01, N85.02, N99.85
Drugs: cisplatin, doxorubicin hydrochloride, paclitaxel
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed endometrial epithelial carcinoma meeting at least 1 of the
             following criteria:

               -  Advanced metastatic and/or relapsed disease

               -  Locally advanced inoperable or unresectable disease

          -  No mixed mesodermal tumor and/or tumors showing evidence of sarcomatous elements

          -  Uterine papillary serous carcinoma allowed

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  WHO 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Neutrophil count greater than 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Hemoglobin greater than 10 g/dL (transfusions allowed)

        Hepatic

          -  ALT and AST less than 2 times upper limit of normal (ULN)

          -  Alkaline phosphatase less than 2 times ULN

          -  Bilirubin less than 1.5 times ULN

        Renal

          -  Creatinine less than 1.5 times ULN

          -  Creatinine clearance greater than 50 mL/min

        Cardiovascular

          -  Normal baseline EKG

          -  Normal baseline LVEF on MUGA or echocardiogram for patients who received prior
             anthracyclines

        Other

          -  Able to tolerate high-dose dexamethasone

          -  Must be considered fit for chemotherapy

          -  No uncontrolled infection

          -  No other malignancy within the past 5 years except successfully treated basal cell
             skin cancer or carcinoma in situ of the cervix

          -  No prior nervous or psychiatric disorder that would preclude study compliance

          -  No psychological, familial, sociological, or geographic condition that would preclude
             study participation

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  At least 12 months since prior adjuvant chemotherapy

          -  Total dose of prior doxorubicin no greater than 200 mg/m^2

          -  Total dose of prior epirubicin no greater than 300 mg/m^2

        Endocrine therapy

          -  At least 28 days since prior hormonal therapy for patients with partial or complete
             response after first-line treatment

        Radiotherapy

          -  No prior radiotherapy to any area other than pelvis

          -  No concurrent radiotherapy

        Surgery

          -  Not specified

        Other

          -  No other concurrent anticancer medications