NCT01450384

Pemetrexed Disodium and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors

Phase I Study of Pemetrexed and Sorafenib in Advanced Malignancy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of giving pemetrexed disodium and sorafenib tosylate together in treating patients with advanced solid tumors. Pemetrexed disodium and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also stop the growth of solid tumors by blocking blood flow to the tumor. Giving pemetrexed disodium together with sorafenib tosylate may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To determine doses for the combination of pemetrexed (pemetrexed disodium) with sorafenib (sorafenib tosylate) appropriate for Phase II study. SECONDARY OBJECTIVES: I. To evaluate the safety, tolerance, and toxicity of the combination of pemetrexed and sorafenib. II. To observe antitumor effects of the combination. OUTLINE: This is a dose-escalation study of pemetrexed disodium and sorafenib tosylate. Patients receive pemetrexed disodium intravenously (IV) on day 1 every 2 weeks and sorafenib tosylate orally (PO) twice daily (BID) on days 1-5. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.

Conditions

• Unspecified Adult Solid Tumor

Interventions

Type	Name	Description
DRUG	sorafenib tosylate	Given PO
DRUG	pemetrexed disodium	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
PROCEDURE	biopsy	Optional correlative studies

Timeline

• Start date: 2011-10-01
• Primary completion: 2015-01-01
• Completion: 2015-09-01
• First posted: 2011-10-12
• Last updated: 2016-02-23

Locations

1 site across 1 country: United States