Sorafenib. ICORG 06-41, V4
RATIONALE: 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.
PURPOSE: This phase II trial is studying how well sorafenib tosylate works in treating patients with relapsed esophageal cancer and/or stomach cancer.
Drug: sorafenib tosylate
Other: laboratory biomarker analysis
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Single Agent Sorafenib in the Treatment of Relapsed Esophageal/Gastric Adenocarcinoma in Platinum Pre-Treated Patients|
- Disease control rate after 4 months [ Time Frame: After 4 months of treatment ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Progression free survival and overall survival probabilities over time will be estimated using Kaplan-Meier plots. Their medians with their confidence intervals will be also presented.
Progression Free Survival is measured from first treatment until the date of disease progression or death, whichever is reported first. Subjects who do not progress or die at the time of the analysis will be censored at the day of their last tumour assessment.
- Overall survival [ Time Frame: Ongoing ] [ Designated as safety issue: No ]Overall survival is measured from the date of first treatment to the date of the subject's death. If the subject is alive or the vital status is unknown, the date of death will be censored at the date that the subject is last known to be alive.
- Time to tumor progression [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
- Objective response rate [ Time Frame: Response would be assessed by appropriate imaging (e.g. CT) every 8 weeks. ] [ Designated as safety issue: No ]The study has been designed to use the disease control rate at 4 months on treatment as the primary endpoint.
- Tolerability and toxicity [ Time Frame: Ongoing for duration of treatment and 30 day follow up. ] [ Designated as safety issue: Yes ]Patients would be assessed for toxicity according to NCI CTC version 3.
|Study Start Date:||February 2009|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
|Experimental: Sorafenib 400mg bd, p.o, continuously||Drug: sorafenib tosylate Other: laboratory biomarker analysis|
- To determine the disease control rate (complete response, partial response, and stable disease) of sorafenib tosylate after 4 months in patients with relapsed esophageal or gastric adenocarcinoma previously treated with platinum-based chemotherapy.
- To determine the progression-free survival of patients treated with this drug.
- To determine the overall survival of patients treated with this drug.
- To determine the time to tumor progression in patients treated with this drug.
- To determine the objective response rate in patients treated with this drug.
- To determine the tolerability and toxicity in patients treated with this drug.
- To assess biomarkers associated with response/resistance to therapy. (exploratory)
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib tosylate twice a day on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Blood and tumor samples may be collected periodically and analyzed for biological markers.
After completion of study treatment, patients are followed up periodically.
|Cork University Hospital|
|Bon Secours Hospital|
|Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital|
|Dublin, Ireland, 24|
|Dublin, Ireland, 9|
|Mater Misericordiae University Hospital|
|Dublin, Ireland, 7|
|St. James's Hospital|
|Dublin, Ireland, 8|
|University College Hospital|
|Waterford Regional Hospital|
|Principal Investigator:||Kenneth O'Byrne, MD||St. James's Hospital, Ireland|