Sorafenib. ICORG 06-41, V4
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|ClinicalTrials.gov Identifier: NCT01158287|
Recruitment Status : Completed
First Posted : July 8, 2010
Last Update Posted : December 31, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Gastric Cancer||Drug: sorafenib tosylate Other: laboratory biomarker analysis||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Single Agent Sorafenib in the Treatment of Relapsed Esophageal/Gastric Adenocarcinoma in Platinum Pre-Treated Patients|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||November 2012|
|Experimental: Sorafenib 400mg bd, p.o, continuously||Drug: sorafenib tosylate Other: laboratory biomarker analysis|
- Disease control rate after 4 months [ Time Frame: After 4 months of treatment ]
- Progression-free survival [ Time Frame: Ongoing ]
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 ]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 ]
- Objective response rate [ Time Frame: Response would be assessed by appropriate imaging (e.g. CT) every 8 weeks. ]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. ]Patients would be assessed for toxicity according to NCI CTC version 3.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158287
|Bon Secours Hospital|
|Cork University Hospital|
|Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital|
|Dublin, Ireland, 24|
|Mater Misericordiae University Hospital|
|Dublin, Ireland, 7|
|St. James's Hospital|
|Dublin, Ireland, 8|
|Dublin, Ireland, 9|
|University College Hospital|
|Waterford Regional Hospital|
|Principal Investigator:||Kenneth O'Byrne, MD||St. James's Hospital, Ireland|