Phase I/II study of Gemcitabine plus weekly Paclitaxel with Metastatic Breast Cancer
Phase 1
- Conditions
- breast cancer
- Registration Number
- JPRN-UMIN000006019
- Lead Sponsor
- Tokai University School of Medicine Division of Breast and Endocrine Surgery Department of Surgery
- Brief Summary
In 1000mg/m2 of gemcitabine dose, DLT was observed in one case of 6 patienrs. This DLT was grade 4 neutropenia. And in 1250mg/m2 of gemcitabine dose, no DLT was observed. Finaly, recomended dose will be 1250mg/m2 of gemcitabine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 47
Inclusion Criteria
Not provided
Exclusion Criteria
Prior administration of gemcitabine Pulmonary fibrosis or pneumonitis Abnormal cardiac function, myocardial infarction within 6 months Body cavity fluid which needs to treatment Active infection Severe complicated situation Severe drug allergic reaction Serious psychiatric illness After bone marrow transplantation After stem cell transplantation Symptomatic systemic brain metastasis Double chemotherapy Pregnancy, breast feeding, suspected pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine maximum tolerated dose and recommended dose
- Secondary Outcome Measures
Name Time Method adverse events time to progression