Sorafenib. ICORG 06-41, V4
- Conditions
- Esophageal CancerGastric Cancer
- Interventions
- Other: laboratory biomarker analysis
- Registration Number
- NCT01158287
- Lead Sponsor
- Cancer Trials Ireland
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* 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.
Secondary
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sorafenib 400mg bd, p.o, continuously laboratory biomarker analysis - Sorafenib 400mg bd, p.o, continuously sorafenib tosylate -
- Primary Outcome Measures
Name Time Method Disease control rate after 4 months After 4 months of treatment
- Secondary Outcome Measures
Name Time Method Progression-free survival 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 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 Ongoing Objective response rate 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 Ongoing for duration of treatment and 30 day follow up. Patients would be assessed for toxicity according to NCI CTC version 3.
Trial Locations
- Locations (8)
Cork University Hospital
🇮🇪Cork, Ireland
Waterford Regional Hospital
🇮🇪Waterford, Ireland
Mater Misericordiae University Hospital
🇮🇪Dublin, Ireland
University College Hospital
🇮🇪Galway, Ireland
Bon Secours Hospital
🇮🇪Cork, Ireland
Beaumont Hospital
🇮🇪Dublin, Ireland
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
🇮🇪Dublin, Ireland
St. James's Hospital
🇮🇪Dublin, Ireland