Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
Advanced Solid Tumors, Cancer, Capecitabine, XELOX, Neoplasms, Oxaliplatin, Bevacizumab, RAD001
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.
Interventions
DRUGcapecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev)
bevacizumab IV, capecitabine oral, oxaliplatin IV, RAD001 oral
Sponsors
Roche-Genentech
Novartis
Herbert Hurwitz
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the MTD/RPTD of capecitabine/oxaliplatin/bevacizumab/everolimus (XELOX-A-Ev) for subjects with advanced solid tumors. | End of treatment phase |
Secondary
| Measure | Time frame |
|---|---|
| Describe dose-limiting and non-dose-limiting toxicities | End of treatment phase |
| preliminarily investigate the response rate and PFS | from response to progression |
Countries
United States
Outcome results
None listed