Pemetrexed Disodium and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors
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.
Unspecified Adult Solid Tumor
Drug: sorafenib tosylate
Drug: pemetrexed disodium
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Pemetrexed and Sorafenib in Advanced Malignancy|
- Recommended phase 2 doses for the combination of pemetrexed disodium with sorafenib tosylate [ Time Frame: At least 4 weeks ] [ Designated as safety issue: Yes ]Maximum doses of pemetrexed and sorafenib, which, when administered in combination are determined to be tolerable and will be tested in a Phase 2 trial for efficacy.
- Number of subjects in whom study treatment produces antitumor effects of the combination [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]Tumor masses will be evaluated for response according to the Response Evaluation Criteria In Solid Tumors (RECIST) Criteria v 1.1
- Number of biopsy specimens that successfully stain for Beclin1 [ Time Frame: Baseline up to 4 weeks ] [ Designated as safety issue: No ]Determine if biopsy specimens can be stained and analyzed for Beclin1. Assessed by use of a repeated measure analysis through a linear mixed model, as well as an ordinal regression analysis.
- Number of biopsy specimens that can be analyzed for PDGFRb expression [ Time Frame: Baseline up to 4 weeks ] [ Designated as safety issue: No ]Assessed by use of a repeated measure analysis through a linear mixed model, as well as an ordinal regression analysis.
- Analysis of pTEN expression in biopsy specimens [ Time Frame: Baseline up to 4 weeks ] [ Designated as safety issue: No ]Assessed by use of a repeated measure analysis through a linear mixed model, as well as an ordinal regression analysis.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (enzyme inhibitor therapy, antiangiogenesis)
Patients receive pemetrexed disodium IV on day 1 every 2 weeks and sorafenib tosylate PO BID for 4 weeks on days 1-5. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Drug: sorafenib tosylate
Other Names:Drug: pemetrexed disodium
Other Names:Other: laboratory biomarker analysis
Correlative studiesProcedure: biopsy
Optional correlative studies
Other Name: biopsies
I. To determine doses for the combination of pemetrexed (pemetrexed disodium) with sorafenib (sorafenib tosylate) appropriate for Phase II study.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01450384
|Contact: Andrew Poklepovic, M.D.||firstname.lastname@example.org|
|United States, Virginia|
|Virginia Commonwealth University/Massey Cancer Center||Recruiting|
|Richmond, Virginia, United States, 23298|
|Contact: Andrew Poklepovic, MD 804-628-2321 email@example.com|
|Contact: Mary B Tombes, NP 804-628-1357 firstname.lastname@example.org|
|Principal Investigator: Andrew Poklepovic, MD|
|Principal Investigator:||Andrew Poklepovic||Massey Cancer Center|