Uterus cancer
Conditions
Interventions
PTX 135 mg/m2 day0 or day1, or 175 mg/m2 day1 iv, CDDP 50 mg/m2 day1 iv, Granisetron 3 mg/body, day0 and 1 iv, Aprepitant 125 mg day1 po, 80 mg day2, 3 po and Dexamethasone 9.9 mg day1 iv, 6.6 m
Sponsors
Hokkaido University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Pathologically diagnosed uterus cancer 2) Patients who voluntarily signed the Institutional Review Board approved written informed consent 3) The uterus cancer notification was given 4) Expected to survive => 3 months 5) Age 20 or older 6) Eastern Cooperative Oncology Group (ECOG) Performance Status Grade of 0 to 2 7) Patients are scheduled to be treated with CDDP and paclitaxel as a first line chemotherapy 8) Patients who are able to take meals orally 9) Laboratory test results within these ranges 1. White blood cell count=>3,000/microliter and <=12,000/microliter 2. Neutrophils=>1,500/microliter 3. Platelets=>100,000/microliter 4. Hemoglobin=>8.0 g/dL 5. AST<=2x upper limit 6. ALT<=2x upper limit 7. Total bilirubin<=2.0 mg/dL 8. K=>3.0 mEg/L 9. Creatinine clearance=>60 mL/min 10. No abnormality in echocardiography
Exclusion criteria
Exclusion criteria: 1)Patients with cerebral metastases 2)Patients with double cancer 3)Patients with seizure disorder requiring anticonvulsants 4)Patients with disturbed consciousness 5)Patients with gastrointestinal obstruction 6)Patients with vomiting or nausea with =>CTCAE v4.0 Grade 2 7)Patients participating in any other clinical trial 8)Patients with uncontrollable hypertension 9)Patients with diabetes mellitus treated with insulin, or uncontrollable diabetes mellitus 10)Patients with taking corticosteroid, androgen, progesterone or any other orexigenic medicine 11)Patients treated with opioids 12)Pregnant woman, Nursing woman, and woman not to agree with contraception 13)Patients with infection requiring systemic treatment 14)Patients having body temperature of =>38 degree at the enrollment 15)Patients with psychiatric disorder or any psychiatric symptoms, and considered in ineligible to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete control rate (no emetic episodes, use of no rescue medications with mild nausea or no nausea) during the 5-day period postcisplatin | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate (no emetic episodes and use of no rescue medications), total control rate, time to treatment failure, appetite (VAS), nausea (VAS), FAACT anorexia and cachexia subscale scores, EORTC-QLQ-C30 scores, grade of appetite/nausea/vomiting byCTCAE v4.0, blood concentration of ghrelin | — |
Countries
Japan
Contacts
Public ContactHidemichi Watari, MD, PhD
Hokkaido University Hospital Dpartment of Gynecology
Outcome results
None listed