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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00849550
Recruitment Status : Completed
First Posted : February 24, 2009
Last Update Posted : December 24, 2012
Information provided by (Responsible Party):
Herbert Hurwitz, Duke University

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: XELOX-A-Ev Drug: capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev)
bevacizumab IV, capecitabine oral, oxaliplatin IV, RAD001 oral

Primary Outcome Measures :
  1. 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 :
  1. Describe dose-limiting and non-dose-limiting toxicities [ Time Frame: End of treatment phase ]
  2. preliminarily investigate the response rate and PFS [ Time Frame: from response to progression ]

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Herbert Hurwitz, Associate Professor of Medicine, Duke University Identifier: NCT00849550     History of Changes
Other Study ID Numbers: Pro00015605
4265 ( Other Identifier: Legacy IRB number )
First Posted: February 24, 2009    Key Record Dates
Last Update Posted: December 24, 2012
Last Verified: December 2012

Keywords provided by Herbert Hurwitz, 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