Clinical trial NCT00849550: Safety and Dosage Study of RAD001 (Everolimus) in Combination With Current Standard of Care to Treat Advanced Solid Tumors.
Official title: A Phase I Study of Capecitabine, Oxaliplatin, Bevacizumab, and RAD001 (XELOX-A-Ev) for Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Cancer
Keywords: Advanced Solid Tumors
Cancer
Capecitabine
XELOX
Neoplasms
Oxaliplatin
Bevacizumab
RAD001
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Roche-Genentech
name: Novartis
First posted: 2009-02-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: To determine the MTD/RPTD of capecitabine/oxaliplatin/bevacizumab/everolimus (XELOX-A-Ev) for subjects with advanced solid tumors.
timeFrame: End of treatment phase
Secondary outcomes:
measure: Describe dose-limiting and non-dose-limiting toxicities
timeFrame: End of treatment phase
measure: preliminarily investigate the response rate and PFS
timeFrame: from response to progression
Other outcomes:
Locations:
city: Harvey
country: United States
facility: Ingalls Cancer Research Center
state: Illinois
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
Study officials:
affiliation: Duke University
name: Herbert Hurwitz, MD
role: PRINCIPAL_INVESTIGATOR
References: