A feasibility study of doxorubicin plus trabectedin combination therapy for leiomyosarcoma
- Conditions
- Leiomyosarcoma
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
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
<Cockcroft-Gault formula>
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 <= 1.5 mg/dL
(13) ALT <= 2.5 x the upper limit of the institutional normal range
(14) AST <= 2.5 x the upper limit of the institutional normal range
(15) ALP <= 2.5 x the upper limit of the institutional normal range (unless caused by the primary disease)
(16) Left ventricular ejection fraction (LVEF) on echocardiography >= 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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method - Completion rate of 6 courses of doxorubicin + trabectedin therapy.
- Secondary Outcome Measures
Name Time Method