Sorafenib, Pemetrexed, and Cisplatin in Treating Patients With Advanced Solid Tumors
RATIONALE: Sorafenib and pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with pemetrexed and cisplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib when given together with pemetrexed and cisplatin in treating patients with advanced solid tumors.
Head and Neck Cancer
Drug: pemetrexed disodium
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Sorafenib, Pemetrexed, and Cisplatin for the Treatment of Advanced Solid Tumors.|
- Maximum tolerated dose of sorafenib tosylate [ Time Frame: From first dose to toxicity event ] [ Designated as safety issue: Yes ]This dose level is declared to be above the maximum tolerated dose (MTD) and dose escalation is stopped. Declare the next lower dose the MTD if 6 patients have already been treated at that dose.
- Disease Response [ Time Frame: At 6- 8 weeks ] [ Designated as safety issue: No ]
Each patient will be assigned one of the following Response Evaluation Criteria in Solid Tumors (RECIST) categories:
- complete response;
- partial response;
- stable disease;
- progressive disease;
- early death from malignant disease;
- unknown (insufficient evaluation to determine response status).
- Maximum, Minimum and AUC Concentrations of Sorafenib [ Time Frame: Day 1 to Day 8 ] [ Designated as safety issue: No ]Maximum and minimum serum concentrations and area under the concentration time curve (AUC) for sorafenib will be predicted using standard pharmacokinetic software
|Study Start Date:||May 2008|
|Study Completion Date:||November 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Patients receiving a dose escalation scheme of daily oral sorafenib (200 mg or 400 mg bid) when given in combination with fixed dose intravenous pemetrexed and cisplatin for the treatment of solid tumors.
Cisplatin administered intravenously, 75 mg/m^2 over 1-2 hours on day 1 of a 21 day cycle
Other Names:Drug: pemetrexed disodium
Pemetrexed 500 mg/m^2 intravenously (IV) will be given as a 10-minute intravenous infusion (after cisplatin) on day 1 of a 21 day cycle
Other Names:Drug: sorafenib
daily oral sorafenib (200 mg or 400 mg bid)
- To determine the maximum tolerated dose of sorafenib tosylate when given in combination with pemetrexed disodium and cisplatin in patients with advanced non-squamous cell solid tumor malignancy including, but not limited to, breast, lung, colon, pancreatic, prostate, or head and neck cancer or sarcoma.
- To characterize the quantitative and qualitative toxicities of this regimen in these patients.
- To obtain preliminary information about the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of sorafenib tosylate.
Patients receive oral sorafenib tosylate once daily on days 1-21 and cisplatin IV over 1-2 hours and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 30 days, every 8 weeks until disease progression, and then every 3 months for up to 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703638
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Priya Kumar, MD||Masonic Cancer Center, University of Minnesota|