NCT00703638

Sorafenib, Pemetrexed, and Cisplatin in Treating Patients With Advanced Solid Tumors

Phase I Study of Sorafenib, Pemetrexed, and Cisplatin for the Treatment of Advanced Solid Tumors.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

• Breast Cancer
• Colorectal Cancer
• Head and Neck Cancer
• Lung Cancer
• Mesothelioma
• Pancreatic Cancer
• Prostate Cancer
• Sarcoma

Interventions

Type	Name	Description
DRUG	cisplatin	Cisplatin administered intravenously, 75 mg/m\^2 over 1-2 hours on day 1 of a 21 day cycle
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
DRUG	sorafenib	daily oral sorafenib (200 mg or 400 mg bid)

Timeline

• Start date: 2008-05-01
• Primary completion: 2010-09-01
• Completion: 2010-11-01
• First posted: 2008-06-23
• Last updated: 2017-11-29

Locations

1 site across 1 country: United States