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| Sponsor: | Duke University |
|---|---|
| Collaborators: |
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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Expanded Cohort of Patients With Refractory Metastatic Colorectal Cancer Treated With Bevacizumab and Everolimus |
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2007 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: bevacizumab + everolimus
Bevacizumab 10 mg/kg IV days 1, 15 RAD001 10 mg PO QD days 1-28
Other Name: Avastin + RAD001
|
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.
• The treatment regimen is as follows: 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:
Exclusion Criteria:
Contacts and Locations| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: | Herbert I Hurwitz, MD | Duke University |
More Information
| Responsible Party: | Herbert Hurwitz, MD, Duke University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00597506 History of Changes |
| Other Study ID Numbers: | 1574 |
| Study First Received: | December 26, 2007 |
| Last Updated: | June 25, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
colorectal refractory adenocarcinoma bevacizumab everolimus |
|
Adenocarcinoma Colorectal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
Everolimus Sirolimus Bevacizumab Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents |