Pilot Study of Sorafenib and Bi-weekly Capecitabine in Patients With Advanced Breast and Gastrointestinal Tumors
Overview
- Phase
- Phase 1
- Intervention
- Sorafenib
- Conditions
- Metastatic Breast Cancer
- Sponsor
- Yale University
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Maximum Tolerated Dose / Safety
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to find the maximum tolerated dose of the combination of two drugs. The two drugs are Sorafenib and Capecitabine. The drug Sorafenib is an approved drug which is used to treat certain cancers. The drug Capecitabine is approved to treat patients with advanced breast cancer as well as early stage colon cancer.
Detailed Description
This is a pilot study of Sorafenib combined with Capecitabine in patients with histologically confirmed unresectable or metastatic breast and GI tumors. One cycle will consist of 4 weeks of treatment. The dose of Sorafenib will be 600 mg administered orally daily in divided doses. Capecitabine will be given at a fixed dose of 2000 mg orally BID x 7 days every 14 days
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years.
- •Life expectancy of at least 12 weeks (3 months).
- •ECOG Performance Status 0 or
- •Histologically confirmed unresectable or metastatic breast and/or GI tumors for which curative standard treatments are unavailable
- •Adequate bone marrow, liver and renal function as assessed by the following:
- •Hemoglobin \> 9.0 g/dl
- •Absolute neutrophil count (ANC) \>1,500/mm3
- •Platelet count \> 100,000/mm3
- •Total bilirubin \< 1.5 times ULN
- •ALT and AST \< 2.5 times the ULN ( \< 5 x ULN for patients with liver involvement)
Exclusion Criteria
- •Metastatic brain or meningeal tumors (unless subject completed definitive therapy more than 1 month previously and is stable off steroids).
- •Uncontrolled hypertension defined as systolic blood pressure \> 140 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management.
- •Active or clinically significant cardiac disease including:
- •Congestive heart failure - New York Heart Association (NYHA) \> Class II.
- •Active coronary artery disease.
- •Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
- •Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization.
- •Subject with any pulmonary hemorrhage/bleeding event of NCI-CTCAE v4.0 Grade 2 or higher within 4 weeks of study enrollment; any other hemorrhage/bleeding event of NCI-CTCAE v4.0 Grade 3 or higher within 4 weeks of study enrollment.
- •Major surgery, open biopsy or significant traumatic injury within 30 days of first study drug.
- •Presence of an active non-healing wound, non-healing ulcer, or bone fracture.
Arms & Interventions
Sorafenib and Capecitabine
One cycle will consist of 4 weeks of treatment. The dose of Sorafenib will be 600 mg administered orally daily in divided doses. Capecitabine will be given at a fixed dose of 2000 mg orally BID x 7 days every 14 days
Intervention: Sorafenib
Sorafenib and Capecitabine
One cycle will consist of 4 weeks of treatment. The dose of Sorafenib will be 600 mg administered orally daily in divided doses. Capecitabine will be given at a fixed dose of 2000 mg orally BID x 7 days every 14 days
Intervention: Capecitabine
Outcomes
Primary Outcomes
Maximum Tolerated Dose / Safety
Time Frame: 4 weeks
Primary Objectives: * Safety * Determination of maximum tolerated dose
Secondary Outcomes
- Response(8 Weeks)