- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00849550
Safety and Dosage Study of RAD001 (Everolimus) in Combination With Current Standard of Care to Treat Advanced Solid Tumors. (COBRA)
December 21, 2012 updated by: Herbert Hurwitz
A Phase I Study of Capecitabine, Oxaliplatin, Bevacizumab, and RAD001 (XELOX-A-Ev) for Subjects With Advanced Solid Tumors
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Harvey, Illinois, United States, 60426
- Ingalls Cancer Research Center
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
- Sarah Cannon Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: XELOX-A-Ev
|
bevacizumab IV, capecitabine oral, oxaliplatin IV, RAD001 oral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the MTD/RPTD of capecitabine/oxaliplatin/bevacizumab/everolimus (XELOX-A-Ev) for subjects with advanced solid tumors.
Time Frame: End of treatment phase
|
End of treatment phase
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Describe dose-limiting and non-dose-limiting toxicities
Time Frame: End of treatment phase
|
End of treatment phase
|
preliminarily investigate the response rate and PFS
Time Frame: from response to progression
|
from response to progression
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
February 22, 2009
First Submitted That Met QC Criteria
February 23, 2009
First Posted (Estimate)
February 24, 2009
Study Record Updates
Last Update Posted (Estimate)
December 24, 2012
Last Update Submitted That Met QC Criteria
December 21, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Capecitabine
- Oxaliplatin
- Bevacizumab
- Everolimus
Other Study ID Numbers
- Pro00015605
- 4265 (Other Identifier: Legacy IRB number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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