Pemetrexed Disodium and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors
|ClinicalTrials.gov Identifier: NCT01450384|
Recruitment Status : Completed
First Posted : October 12, 2011
Last Update Posted : February 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor||Drug: sorafenib tosylate Drug: pemetrexed disodium Other: laboratory biomarker analysis Procedure: biopsy||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Pemetrexed and Sorafenib in Advanced Malignancy|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||September 2015|
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
- Recommended phase 2 doses for the combination of pemetrexed disodium with sorafenib tosylate [ Time Frame: At least 4 weeks ]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 ]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 ]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 ]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 ]Assessed by use of a repeated measure analysis through a linear mixed model, as well as an ordinal regression analysis.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01450384
|United States, Virginia|
|Virginia Commonwealth University/Massey Cancer Center|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Andrew Poklepovic||Massey Cancer Center|