A Phase II Study of the Efficacy and Tolerability of the Dose Escalation of Sorafenib in Advanced Renal Cell Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Could Tolerate Each Dose Level
Study Overview
Brief Summary
The purpose of this study is to determine whether an increase in the dose of sorafenib when given over five instead of 7 days/week, will result in an improvement of the response rate (degree of shrinkage of your cancer) and an improvement in the length of time that sorafenib will control your cancer, without causing a significant increase in side effects.
Detailed Description
In 2006, an estimated 38,890 people in the United States were diagnosed with kidney cancer and greater than 12,000 died from the disease. Kidney cancer that has spread to other parts of the body is one of the most treatment-resistant diseases. Standard of care treatment usually involves chemotherapy. Results from chemotherapy have been disappointing. Therefore, there is a need to develop additional safe and effective therapies to treat advanced kidney cancer.
Sorafenib (Nexavar®) has been approved by the FDA for the treatment of advanced kidney cancer. Sorafenib works by interfering with a type of protein in your body that determines how your kidney cells work and grow. Sorafenib at standard doses for 400mg(two pills) twice/day, given seven days/week, may slow progression of the disease for an average of three months but it is not expected to be curative. Preliminary studies have suggested higher doses of sorafenib may increase the chance that the tumor will shrink.
Study Design
- Study Type
- Interventional
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Intra-Patient Dose Escalation: Sorafenib
All patients will receive a starting dose of sorafenib 400 mg by mouth twice daily. At four weeks, all patients who have not experienced Grade 3 or 4 toxicity will undergo dose escalation using a treatment schedule of days 1-5 days of each week. Doses will continue to be escalated every 4 weeks depending on tolerability and tumor response.
Intervention: sorafenib (Drug)
Outcomes
Primary Outcomes
Number of Participants Who Could Tolerate Each Dose Level
Time Frame: 12 weeks
Tolerability will be defined as successful completion of the dose level without experiencing Grade 3 or 4 toxicity.
Secondary Outcomes
- Overall Number of Participants That Had Disease Progression on Study(26 months)