Safety and Dosage Study of RAD001 (Everolimus) in Combination With Current Standard of Care to Treat Advanced Solid Tumors.

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Study of Capecitabine, Oxaliplatin, Bevacizumab, and RAD001 (XELOX-A-Ev) for Subjects With Advanced Solid Tumors

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific, Cancer

Intervention / Treatment
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* Drug: capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XELOX-A-Ev<br> | Drug: capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev)<br>* bevacizumab IV, capecitabine oral, oxaliplatin IV, RAD001 oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Solid Tumors, Cancer, Capecitabine, XELOX, Neoplasms, Oxaliplatin, Bevacizumab, RAD001