Status:
COMPLETED
Safety and Dosage Study of RAD001 (Everolimus) in Combination With Current Standard of Care to Treat Advanced Solid Tumors.
Lead Sponsor:
Herbert Hurwitz
Collaborating Sponsors:
Roche-Genentech
Novartis
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00849550
Start Date
July 1 2009
End Date
December 1 2012
Last Update
December 24 2012
Active Locations (3)
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1
Ingalls Cancer Research Center
Harvey, Illinois, United States, 60426
2
Duke University Medical Center
Durham, North Carolina, United States, 27710
3
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203