advanced/recurrent malignant soft tissue tumor Malignant soft tissue tumor
Conditions
Interventions
Eribulin/ Pazopanib combination chemotherapy
Phase I study, Chemotherapy, Eribulin, Pazopanib
Sponsors
Takehara Kazuhiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed advanced or recurrent malignant soft-tissue sarcoma 2. Eastern Cooperative Oncology Group (ECOG) Performance status (PS): 0-2 3. Age > 20-years 4. At least 4 weeks interval from previous treatment 5. Prior chemotherapy 1,500/mm3 Haemoglobin level > 9.0 g/dL Platelet > 100,000/mm3 AST (GOT), ALT (GPT) level 50 mL/min 7. Good hypertensive management: BP 50% 10. to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Active infectious diseases 2. Histologically confirmed malignant soft tissue tumor, which is established the standard first-line chemotherapy 3. With active double cancer 4. Previous malignant disease 5. With severe complications such as medically uncontrolled cardiovascular illness, cirrhosis, uncontrollable malignant hypertension 6. To encounter serious disease within 6 months such as myocardial infarction, interstitial pneumonia, pulmonary fibrosis, intestinal obstruction, massive ascites/pleural effusion 7. With interstitial pneumonia, pulmonary fibrosis 8. With intestinal palsy, intestinal obstruction 9. With celom fluid storage requiring treatment 10. With active hepatitis B 11. Be pregnant or breastfeeding 12. With serious drug hypersensitivity 13. Physicians judged to be ineligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The maximum tolerable dose of Eribulin/ Pazopanib combination chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate safety and efficacy of Eribulin/ Pazopanib combination chemotherapy for patients with malignant soft tissue tumor | — |
Contacts
Public ContactHideki Tokunaga
Tohoku University Hospital
Outcome results
None listed