uterine carcinosarcoma
Conditions
Interventions
triweekly administration of paclitaxel 175mg/m2 and carboplatin AUC6 for 6 cycles
weekly administration of paclitaxel 80mg/m2 every week and triweekly administration of carboplatin AUC6 for 6 cycles
Sponsors
Japanese Gynecologic Oncology Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Patients who have been diagnosed with FIGO Stage I-IV uterine carcinosarcoma by histopathology of isolated tissues, and patients with recurrent uterine carcinosarcoma who have been confirmed to have distant metastasis at the first onset. Patients who have not undergone hysterectomy are also included in this study if the patients have been diagnosed with uterine carcinosarcoma by biopsy or curettage specimens. 2) Patients who have not undergone chemotherapy before radiotherapy. The period from the completion of radiotherapy to the beginning of protocol treatment should be at least 4 weeks. 3) Patients with ECOG performance status of 0-2 4) Patients who have undergone surgery within 8 weeks before adjuvant treatment. 5) 20 years of age and older (at registration) 6) Patients must have normal hematologic, renal and hepatic function: Granulocytes >=1500/mcl, platelets >=75000/mcl and hemoglobin >=10 g/dL Creatinine <=1.5x institutional normal Bilirubin <=1.5x institutional normal AST and ALP <=3x institutional normal Neuronal function: </=Grage 1 of neuropathy (motor, sense) (CTCAE ver. 4). 7) Patients who have provided written informed consent for the participation in this study.
Exclusion criteria
Exclusion criteria: 1) Patients with infectious disease requiring antimicrobial agent. 2) Patients who have undergone chenotherapy for the primary disease. 3) Patients with a history of other invasive malignancies, with the exception of intraepithelial carcinoma of the uterine cervix, non-melanoma skin cancer, if there is any evidence of other malignancy being present within the last 5 years. Patients are also excluded if their previous cancer treatment contraindicates this protocoltherapy. 4) Patients with serious complication (e.g. heart disease, uncontrollable diabetes mellitus, malignant hypertension, bleeding tendency). 5) Patients with active multiple cancers. 6) Patients with pneumonitis or pulmonary fibrosis. 7) Patients with fluid retention requiring treatment. 8) Patients with repeated gastrointestinal bleeding requiring blood products. 9) Patients with a history of unstable angina or myocardial infarction within 6 months before registration, or with complicated severe arrhythmia requiring treatment. However, patients with abnormal cardiac conduction system (e.g. fascicular block, bundle branch block) who have been stable for 6 months before registration is not excluded. 10) Patients who have a contraindication to paclitaxel and carboplatin. 11) Patients with intestinal paralysis or ileus. 12) Patients with a history of severe drug hypersensitivity or allergy. 13) Patients who have been judged to be inappropriate for this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, response rate, adverse events | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactKenichi Harano
National Cancer Center Hospital East Department of Experimental Therapeutics
Outcome results
None listed