A Two Arm Phase I Trial of Sorafenib in Combination With Cisplatin/Etoposide or Carboplatin/Pemetrexed in Patients With Solid Tumors
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Recommended phase II dose and maximum tolerated dose of sorafenib tosylate when administered in combination with cisplatin and etoposide or carboplatin and pemetrexed disodium
12 months
Yes
Thomas E. Stinchcombe, MD
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
United States: Federal Government
LCCC 0613
NCT00573690
September 2007
February 2011
Name | Location |
---|---|
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |