Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
UNC Lineberger Comprehensive Cancer Center
With
OBJECTIVES: Primary * To determine the recommended phase II dose and maximum tolerated dose of sorafenib tosylate when administered in combination with cisplatin and etoposide or carboplatin and pemetrexed disodium in patients with metastatic solid tumors. Secondary * To characterize the toxicities of these regimens in these patients. * To evaluate the efficacy of these regimens in these patients, as measured by RECIST criteria or by tumor markers, if applicable (e.g., PSA, CA-125). * To determine the pharmacokinetics of sorafenib tosylate when administered in combination with etoposide in these patients (samples are no longer being collected and studies are no longer being performed as of 1/8/09). OUTLINE: Patients are assigned to 1 of 2 treatment groups. * Group 1: Patients receive cisplatin IV over 1 hour on day 2 of courses 1 and 2 and on day 1 of all subsequent courses; etoposide IV over 30 minutes on days 1-3; and oral sorafenib tosylate once or twice daily on days 1-21. Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression. * Group 2: Patients receive carboplatin IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Patients also receive sorafenib tosylate as in group 1. Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression. Patients in group 1 undergo blood sample collection on day 1 of courses 1 and 2 for pharmacokinetic studies (samples are no longer being collected and studies are no longer being performed as of 1/8/09). After finishing treatment, patients are followed at 30 days.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
