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

This study has been completed.
Information provided by (Responsible Party):
Herbert Hurwitz, Duke University Medical Center Identifier:
First received: February 22, 2009
Last updated: December 21, 2012
Last verified: December 2012
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.

Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Capecitabine, Oxaliplatin, Bevacizumab, and RAD001 (XELOX-A-Ev) for Subjects With Advanced Solid Tumors

Resource links provided by NLM:

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Describe dose-limiting and non-dose-limiting toxicities [ Time Frame: End of treatment phase ]
  • preliminarily investigate the response rate and PFS [ Time Frame: from response to progression ]

Enrollment: 32
Study Start Date: July 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: XELOX-A-Ev Drug: capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev)
bevacizumab IV, capecitabine oral, oxaliplatin IV, RAD001 oral


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00849550

United States, Illinois
Ingalls Cancer Research Center
Harvey, Illinois, United States, 60426
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Herbert Hurwitz
Principal Investigator: Herbert Hurwitz, MD Duke University
  More Information

Responsible Party: Herbert Hurwitz, Associate Professor of Medicine, Duke University Medical Center Identifier: NCT00849550     History of Changes
Other Study ID Numbers: Pro00015605
4265 ( Other Identifier: Legacy IRB number )
Study First Received: February 22, 2009
Last Updated: December 21, 2012

Keywords provided by Duke University:
Advanced Solid Tumors

Additional relevant MeSH terms:
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents processed this record on April 26, 2017