Sorafenib Tosylate in Treating Patients With Progressive Metastatic Neuroendocrine Tumors
This phase II trial is studying how well sorafenib tosylate works in treating patients with progressive metastatic neuroendocrine tumors. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Metastatic Gastrointestinal Carcinoid Tumor
Pancreatic Polypeptide Tumor
Recurrent Gastrointestinal Carcinoid Tumor
Recurrent Islet Cell Carcinoma
Drug: sorafenib tosylate
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Bay 43-9006 in Progressive Metastatic Neuroendocrine Tumors|
- Confirmed response rate (CR or PR) estimated by the number of successes divided by the total number of evaluable patients [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Kaplan-Meier methodology will be used to estimate the final success proportion (i.e., confirmed response rate with a 95% confidence interval).
- Toxicity defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
- Biochemical levels and response defined as reduction in elevated hormone level by at least 50% or normalization of an elevated value [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Changes in hormone levels will be assessed via summary statistics, graphical techniques, and nonparametric methods, as well as correlated with radiographic response.
- Survival time [ Time Frame: From registration to death due to any cause, assessed up to 2 years ] [ Designated as safety issue: No ]Estimated using the method of Kaplan-Meier.
- Time to disease progression [ Time Frame: From randomization to documentation of disease progression, assessed up to 2 years ] [ Designated as safety issue: No ]Estimated using the method of Kaplan-Meier.
- Duration of response [ Time Frame: The date from which the patients objective status is first noted to be either a CR or PR to the date progression is documented, assessed up to 2 years ] [ Designated as safety issue: No ]Descriptively summarized and graphically evaluated.
- Time to treatment failure [ Time Frame: From the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, refusal, or death, assessed up to 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2005|
|Estimated Primary Completion Date:||January 2100 (Final data collection date for primary outcome measure)|
Experimental: Treatment (sorafenib tosylate)
Patients receive oral sorafenib twice daily on days 1-28.
Drug: sorafenib tosylate
I. To determine the objective tumor response rate of BAY 43-9006 (sorafenib tosylate) in patients with advanced neuroendocrine tumors.
I. Adverse event rate(s). II. Progression free survival and time to progression. III. Improvement in circulating hormone levels. IV. Overall survival.
OUTLINE: This is a multicenter study. Patients are stratified according to tumor type (carcinoid vs islet cell/other well-differentiated tumor).
Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 2 years from study entry.
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Timothy Hobday||Mayo Clinic|