Leiomyosarcoma
Conditions
Interventions
Doxorubicin + Trabectedin Combination Therapy
1. Dexamethasone 16.5 mg IV drip as premedication 30 minutes before the start of doxorubicin
2. Doxorubicin 60 mg/m2 IV drip
3. Trabectedin 1.1 mg/m2 IV d
Sponsors
Maeda Osamu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria: (1) Histopathologically confirmed diagnosis of leiomyosarcoma (2) No prior history of chemotherapy for leiomyosarcoma (3) Patients with locally advanced tumor diagnosed as unresectable by consultation with a surgeon, patients with distant metastasis, or patients of recurrence after surgical resection (4) Age: 18 years or older (5) ECOG performance status: 0 or 1 (6) No concurrent active malignancy. However, eligibility is allowed if the leiomyosarcoma is predicted to determine the prognosis, such as when other malignancies are early-stage cancers or slowly growing lesions. (7) Neutrophil count >= 1,500/mm3 (8) Hemoglobin >= 9.0 g/dL (allowing for increases due to blood transfusion) (9) Platelet count >= 100,000/mm3 (10) Albumin >= 2.5 g/dL (11) Creatinine clearance (calculated using the Cockcroft-Gault formula) >= 30 mL/min Ccr (mL/min) = Weight (kg) x (140 - Age) / (72 x Serum creatinine level (mg/dL)) For women, multiply the obtained value by 0.85. (12) Serum bilirubin = 50% (17) Creatine phosphokinase (CPK) <= 2.5 x the upper limit of the institutional normal range (18) Written informed consent obtained (19) In the case of women of childbearing potential, appropriate contraception (oral contraceptives (progestin/estrogen combination), intrauterine device, or male partner's condom) must be used during trabectedin administration and for 7 months after the final dose. (20) In the case of men, condoms must be used for contraception during trabectedin administration and for 4 months after the final dose.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria should not be included in this study: (1) History of treatment with anthracycline-based drugs or trabectedin. (2) Pregnant or potentially pregnant patients, and breastfeeding patients. (3) Other patients deemed inappropriate by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion rate of 6 courses of doxorubicin + trabectedin therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to treatment failure, progression-free survival, overall survival, response rate, incidence of adverse events, incidence of Grade 3 or higher adverse events, incidence of Grade 4 or higher hematologic toxicity, incidence of febrile neutropenia, rate of tumor resection after study treatment | — |
Contacts
Public ContactOsamu Maeda
Nagoya University Hospital
Outcome results
None listed