Phase I study of gemcitabine and carboplatin plus sorafenib in patients with advanced solid tumors - Phase I study Gemcitabine and carboplatin plus sorafenib

Antoni van Leeuwenhoek Ziekenhuis0 sites28 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sponsor

Antoni van Leeuwenhoek Ziekenhuis

•Patients with progressive advanced solid tumor who are considered for palliative gemcitabine plus carboplatinb combination chemotherapy.
•Furthermore:
•\> 18 years.
•Performance: WHO 0 \- 2\.
•Life expectancy \> 3 months.
•Histological or cytological proof of malignancy.
•Measurable disease according to RECIST criteria.
•Minimal acceptable safety laboratory values.
•o ANC of \>\= 1\.5 × 109/L
•o Platelet count of \>\= 100 × 109/L

•Previous investigational cytotoxic or biological treatment for malignant disease within 30 days before the start of the study.
•Any treatment with non\-oncological investigational drugs within 30 days before the start of the study.
•Radiotherapy within 2 weeks prior to study entry.
•Major surgery within 4 weeks prior to study treatment.
•Patients using medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of sorafenib.
•Pregnancy or breast feeding (all women of childbearing potential must have a pregnancy test before inclusion in the study; post\-menopausal women must have amenorrhoea for at least 12 months). All patients must use adequate contraceptive protection.
•History of alcoholism, drug addiction, or any psychiatric or psychological condition, which in the opinion of the investigator would impair study compliance.
•Concurrent or previous malignancy of a different tumour type within five years of starting the study except for adequately treated non\-melanoma skin cancer or cervical intraepithelial neoplasia
•Legal incapacity
•Uncontrolled or poorly controlled hypertension (Systolic blood pressure \>\= 150 mmHg, diastolic blood pressure \>\= 90 mmHg). Initiation or adjustment of blood pressure medications is permitted prior to study treatment provided that 3 consecutive BP readings are less than 150/90 mmHg, each separated by at least 24 hours