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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.
Sponsor:
Collaborators:
Roche-Genentech
Novartis
Information provided by (Responsible Party):
Herbert Hurwitz, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00849550
First received: February 22, 2009
Last updated: December 21, 2012
Last verified: December 2012
History of Changes
  Purpose

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
Cancer
 Drug: capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849550

Locations
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
Roche-Genentech
Novartis
Investigators
Principal Investigator: Herbert Hurwitz, MD Duke University
  More Information

No publications provided

Responsible Party: Herbert Hurwitz, Associate Professor of Medicine, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00849550     History of Changes
Other Study ID Numbers: Pro00015605, 4265
Study First Received: February 22, 2009
Last Updated: December 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
Advanced Solid Tumors
Cancer
Capecitabine
XELOX
 Neoplasms
Oxaliplatin
Bevacizumab
RAD001

Additional relevant MeSH terms:
Neoplasms
Oxaliplatin
Capecitabine
Bevacizumab
Sirolimus
Fluorouracil
Everolimus
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antifungal Agents
 Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013