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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Millennium Pharmaceuticals, Inc. |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00479128 |
Primary Objective:
-Find dose pairs of Bortezomib & Gemcitabine/Doxorubicin that have acceptable posterior probability of toxicity (target 30%).
Secondary Objectives:
Condition | Intervention | Phase |
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Solid Tumor Urethral Cancer |
Drug: Bortezomib Drug: Gemcitabine Drug: Doxorubicin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Two-Dimensional Dose-Finding Study of Bortezomib in Combination With Gemcitabine/Doxorubicin in Metastatic Surgically Unresectable Urothelial Cancer or Other Solid Tumors |
Estimated Enrollment: | 80 |
Study Start Date: | September 2006 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Bortezomib + Gemcitabine + Doxorubicin
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Drug: Bortezomib
0.8 mg/m^2 IV Over 3-5 Seconds
Drug: Gemcitabine
225 mg/m^2 IV Up to 90 Minutes
Drug: Doxorubicin
12.5 mg/m^2 IV Over 15-30 minutes
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Gemcitabine and doxorubicin are designed to disrupt the growth of cancer cells, which causes cancer cells to start to die. Bortezomib is designed to enter cells and interfere with a substance found inside cells that is responsible for allowing cells to divide. This helps to kill the tumor cells.
Before you can start receiving the study drugs, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a physical exam, including measurement of your vital signs (temperature, heart rate, breathing rate, and blood pressure), height, and weight. You will have a chest x-ray. You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart). You will have an echocardiogram or a MUGA scan. These scans use sound waves to make pictures of your heart, which helps show how well your heart pumps blood. You will be asked to lie on your left side while a technician places a probe with gel on your chest to create images of your heart to determine the function and size.
Depending on the stage of the disease, you will have a computerized tomography (CT) scan and/or a bone scan. Blood (about 3 teaspoons) will be drawn for routine tests and for a pregnancy test (for women who are able to have children). You must have a negative blood or urine pregnancy test before starting the study. You will be asked if you would like to have a central venous catheter (CVC) line placed. A central venous catheter is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure.
If you are found to be eligible to take part in this study, you will receive doses of the study drugs based on when you join the study and how many people have started before you. Two (2) participants will be entered into each dose level. Additional participants may be added at a dose level if it is being well tolerated. The doses will increase until the highest tolerable dose is found.
You will receive the 3 study drugs on the first day of each cycle. You will receive gemcitabine for up to 90 minutes. Next you will receive doxorubicin over 15-30 minutes. Bortezomib will be given last over 3-5 seconds. Every 14 days is considered a study "cycle."
While on study, you will have a complete physical exam before each dose of study drugs. Blood (about 3 teaspoons) will be drawn to check bone marrow and kidney function each week during the first month. The study doctor may decide to draw blood more often, if you are having side effects to the study drugs. Your vital signs will be measured before you receive the study drugs and 1 hour after the infusion.
At the end of Cycle 3, your tumor status will be re-evaluated. You will have CT scans and a bone scan. Blood (about 2 tablespoons) will be drawn for routine tests.
You will be taken off study if the disease gets worse or intolerable side effects occur. If you have stable disease, you may continue receiving therapy as long as your physician feel you are benefiting.
Once you are off-study, you will receive a phone call every 6 months. You will be asked how you are doing, the status of the disease, and if you have had other treatments.
This is an investigational study. Gemcitabine, doxorubicin, and bortezomib are all FDA approved and commercially available. Their use in this study is considered investigational because they have not been approved in patients with urothelial cancer. Up to 80 patients will take part in this study. All will be enrolled at M. D. Anderson.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Arlene Siefker-Radtke, MD | 713-792-2830 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Arlene Siefker-Radtke, MD |
Principal Investigator: | Arlene Siefker-Radtke, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Arlene Siefker-Radtke, MD/Assistant Professor ) |
Study ID Numbers: | 2006-0014 |
Study First Received: | May 24, 2007 |
Last Updated: | December 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00479128 |
Health Authority: | United States: Institutional Review Board |
Solid Tumor Bladder Cancer Ureteral Cancer Urothelial Cancer Urethral Cancer Renal Pelvis Tumor Bortezomib Gemcitabine Doxorubicin |
Gemzar Adriamycin Velcade LDP-341 MLN341 PS-341 Gemcitabine Hydrochloride AD Hydroxydaunomycin hydrochloride |
Bortezomib Urinary Bladder Neoplasms Urogenital Neoplasms Urologic Neoplasms Doxorubicin Signs and Symptoms Urethral cancer |
Urologic Diseases Urethral Neoplasms Gemcitabine Pelvic Neoplasms Urinary tract neoplasm Bladder neoplasm |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Antibiotics, Antineoplastic |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Protease Inhibitors Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Urethral Diseases |