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| Sponsors and Collaborators: |
Duke University Novartis Pharmaceuticals Genentech |
|---|---|
| Information provided by: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00597506 |
Purpose
The purpose of this study is to find the safest and most effective dose of the drugs bevacizumab and everolimus given in combination for the treatment of metastatic colorectal cancer. Bevacizumab (also called Avastin™) is a drug that is given intravenously (through a vein). Everolimus (also called RAD001) is a tablet that is taken by mouth.
Bevacizumab is a protein that is thought to prevent the formation of blood vessels tumors need to grow. RAD001 has multiple capabilities, like bevacizumab it may prevent the formation of blood vessels needed by tumors and it also may stop tumor growth.
This study will try to find the safest dose of these drugs that can be tolerated when taken in combination. The study will look at how the drugs work in the body, and will see if there is any effect on metastatic colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Adenocarcinoma |
Drug: bevacizumab + everolimus |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Expanded Cohort of Patients With Refractory Metastatic Colorectal Cancer Treated With Bevacizumab and Everolimus |
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: bevacizumab + everolimus
Bevacizumab 10 mg/kg IV days 1, 15 RAD001 10 mg PO QD days 1-28
|
This open-label, non-randomized expanded cohort trial of bevacizumab and RAD001 for patients with refractory metastatic colorectal cancer is designed to assess preliminary efficacy as well as the safety and tolerability of this combination. Patients will be accrued to this study at Duke University Medical Center and The Duke Oncology Outreach Network (DON)
After satisfying eligibility and screening criteria, patients will be treated on 28 day cycles.
Bevacizumab 10 mg/kg IV days 1, 15 RAD001 10 mg PO QD days 1-28
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must not have had major surgery within the 28 days prior to study day 1 or minor surgical procedures within the 7 days prior to study day
1.
Exclusion Criteria:
Contacts and Locations| Contact: Amy Franklin, BA | 919-668-6701 | Amy.Franklin@duke.edu |
| Contact: Anthony Amara, MSW | 919-668-1861 | Anthony.Amara@duke.edu |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Anothony Amara, MSW 919-668-1861 Anthony.Amara@duke.edu | |
| Contact: Christy Arrowood, RN 919-668-1861 Wanda.Honeycutt@duke.edu | |
| Principal Investigator: | Herbert I Hurwitz, MD | Duke University |
More Information
| Responsible Party: | Duke University Medical Center ( Herbert Hurwitz, MD ) |
| Study ID Numbers: | 1574 |
| Study First Received: | December 26, 2007 |
| Last Updated: | March 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00597506 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
colorectal refractory adenocarcinoma bevacizumab everolimus |
|
Everolimus Digestive System Neoplasms Immunologic Factors Gastrointestinal Diseases Colonic Diseases Bevacizumab Intestinal Diseases Angiogenesis Inhibitors Immunosuppressive Agents |
Rectal Diseases Intestinal Neoplasms Carcinoma Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
|
Immunologic Factors Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases Physiological Effects of Drugs Bevacizumab Rectal Diseases Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Everolimus Digestive System Neoplasms Neoplasms by Histologic Type |
Growth Substances Intestinal Diseases Immunosuppressive Agents Angiogenesis Inhibitors Intestinal Neoplasms Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Colorectal Neoplasms Neoplasms, Glandular and Epithelial |