Tipifarnib and Sorafenib Tosylate in Treating Patients With Biopsiable Advanced Cancer
This phase I trial studies the side effects and best dose of tipifarnib when given together with sorafenib tosylate in treating patients with biopsiable advanced cancer. Tipifarnib and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: sorafenib tosylate
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 Tipifarnib (R115777) and Sorafenib (BAY 43-9006) in Patients With Biopsiable Advanced Cancers|
- MTD defined as the highest dose level in which fewer than 2 patients experience a dose limiting toxicity as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]Descriptive statistics and graphical analysis will be used to summarize the data. Categorical variables will be summarized in frequency tables.
- Clinical response evaluated using Response Evaluation Criteria In Solid Tumors criteria [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]Descriptive statistics and graphical analysis will be used to summarize the data. For continuous variables, we will use the mean (standard deviation) or median (range) to summarize outcomes.
- Signaling pathway inhibition in tumor tissue by RPPA [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]The analysis of the activated signaling pathways using Pathway Analysis (Ingenuity) will determine whether particular molecular profiles are likely to respond to tipifarnib and sorafenib.
|Study Start Date:||October 2005|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (sorafenib tosylate, tipifarnib)
Patients receive sorafenib tosylate PO QD or BID on days 1-28 and tipifarnib PO QD or BID on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Drug: sorafenib tosylate
Other Names:Drug: tipifarnib
Other Names:Other: laboratory biomarker analysis
I. To evaluate the safety and toxicity and to determine maximum tolerated dose (MTD) of tipifarnib in combination with sorafenib (sorafenib tosylate).
I. Preliminary assessment of tipifarnib and sorafenib efficacy (objective response).
II. To determine signaling pathway profiles of patients treated with tipifarnib and sorafenib who are amenable to biopsy by reverse phase protein microarray (RPPA) analysis.
OUTLINE: This is a dose-escalation study of tipifarnib.
Patients receive sorafenib tosylate orally (PO) once daily (QD) or twice daily (BID) on days 1-28 and tipifarnib PO QD or BID on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 4 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00244972
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||David Hong||M.D. Anderson Cancer Center|