Safety and Dosage Study of RAD001 (Everolimus) in Combination With Current Standard of Care to Treat Advanced Solid Tumors.
Phase 1
Completed
- Conditions
- Unspecified Adult Solid Tumor, Protocol SpecificCancer
- Interventions
- Drug: capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev)
- Registration Number
- NCT00849550
- Lead Sponsor
- Herbert Hurwitz
- Brief Summary
The purpose of this study is to determine if RAD001 (everolimus) helps improve the standard treatment of XELOX-A (bevacizumab, oxaliplatin, capecitabine) in advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
- Must be 18 years or older
- Must have a performance status of at least 70% (able to carry on most normal activities)
- Must have life expectancy of at least 3 months
- Must have adequate organ and marrow function as determined by lab tests
- Women of child-bearing potential and men must agree to use two forms of contraception
- Ability and willingness to sign a written informed consent document
- Histologically confirmed solid tumor malignancy that is metastatic or unresectable
Exclusion Criteria
- Pregnant or breastfeeding and/or lactating women
- Patients who have received any other investigational agents within 28 days of the first day of study drug
- Patients with known CNS metastases
- History of other carcinomas within last 5 years (except non-melanoma skin cancer, in-situ cervical cancer, localized prostate cancer)
- Inadequately controlled hypertension
- Significant vascular disease
- Invasion or encasement of a major artery
- Evidence of bleeding diathesis or coagulopathy
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to day 1 of study drug
- Serious illness or medical condition
- History of myocardial infarction, unstable angina, cardiac or other vascular stenting
- History of stroke
- HIV, Hepatitis C, Hepatitis B or other serious chronic infection
- Impairment of Gastrointestinal function or disease
- History of interstitial lung disease
- Patients who have had radiation therapy, hormonal therapy, biologic therapy or chemotherapy for cancer within 28 days of receiving study drug.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description XELOX-A-Ev capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev) -
- Primary Outcome Measures
Name Time Method To determine the MTD/RPTD of capecitabine/oxaliplatin/bevacizumab/everolimus (XELOX-A-Ev) for subjects with advanced solid tumors. End of treatment phase
- Secondary Outcome Measures
Name Time Method Describe dose-limiting and non-dose-limiting toxicities End of treatment phase preliminarily investigate the response rate and PFS from response to progression
Trial Locations
- Locations (3)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Ingalls Cancer Research Center
🇺🇸Harvey, Illinois, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States