Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer
- Registration Number
- NCT00604409
- Lead Sponsor
- Fox Chase Cancer Center
- Brief Summary
This trial is testing the safety of combining the oral chemotherapy drug capecitabine with radio-labeled microspheres injected directly into the liver.
- Detailed Description
Patients with adequate liver function and performance status in whom liver-directed therapy and capecitabine would be appropriate are eligible for this clinical trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
- Adequate liver function
- Adequate performance status
Exclusion Criteria
- Significant extrahepatic disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (SIRT and capecitabine) SIRT Patients receive capecitabine PO twice daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo SIRT on day 2 and may undergo a second course of SIRT on day 58. Treatment (SIRT and capecitabine) capecitabine Patients receive capecitabine PO twice daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo SIRT on day 2 and may undergo a second course of SIRT on day 58.
- Primary Outcome Measures
Name Time Method To determine the safety, toxicity, and recommended phase II dose (RPTD) of capecitabine when administered concurrently with SIR-Spheres in patients with advanced cancer. ongoing
- Secondary Outcome Measures
Name Time Method Efficacy response rate
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie capecitabine's synergy with SIR-Spheres in liver-directed cancer therapy?
How does SIRT therapy compare to standard-of-care treatments for metastatic hepatocellular carcinoma in phase I trials?
Which biomarkers correlate with improved outcomes in capecitabine and SIR-Spheres combination therapy for cholangiocarcinoma?
What are the most common adverse events associated with capecitabine and Y-90 microsphere therapy in advanced liver cancer patients?
Are there alternative radiosensitizing agents to capecitabine for enhancing SIR-Spheres efficacy in metastatic liver tumors?
Trial Locations
- Locations (1)
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center🇺🇸Philadelphia, Pennsylvania, United States