Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Hoosier Oncology Group Genentech Eli Lilly and Company Walther Cancer Institute |
---|---|
Information provided by: | Hoosier Oncology Group |
ClinicalTrials.gov Identifier: | NCT00234494 |
Cisplatin is a very important agent for the treatment of TCC as it has a single agent response rate of approximately 15%. However, it has been most important as a part of combination chemotherapy, MVAC initially and now in combination with gemcitabine. Single agent gemcitabine has demonstrated an overall response rate (ORR) of approximately 25%, including some complete responses (CR), with minimal toxicity in patients with advanced bladder cancer. Bevacizumab, a murine anti-human VEGF monoclonal antibody, has been advanced for use in combination with cytotoxic chemotherapy to delay time to disease progression in patients with metastatic solid tumors.
This trial is designed to further assess the efficacy, safety and tolerability of this regimen in this patient population.
Condition | Intervention | Phase |
---|---|---|
Bladder Cancer |
Drug: Cisplatin Drug: Gemcitabine Drug: Bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of Cisplatin, Gemcitabine and Bevacizumab in Combination for Metastatic Transitional Cell Cancer: Hoosier Oncology Group GU04-75 |
Estimated Enrollment: | 45 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Cisplatin + Gemcitabine + Bevacizumab
|
Drug: Cisplatin
Cisplatin 70 mg/m2, day 1
Drug: Gemcitabine
Gemcitabine 1250 mg/m2, day 1 and 8
Drug: Bevacizumab
Bevacizumab 15mg/kg, day 1
|
OUTLINE: This is a multi-center study.
Review toxicity every cycle (every 3 weeks) Review for radiographic response every 2 cycles (every six weeks)
Progressive disease = off protocol therapy
Patients will be treated for up to a maximum of 8 cycles of cisplatin and gemcitabine (24 weeks of therapy). If a patient has not progressed by the end of 24 weeks (completion of cisplatin and gemcitabine), then patient will be treated with bevacizumab at 15 mg/kg every three weeks for a maximum of 12 months of bevacizumab therapy (since study entry).
If at any time patient has undue toxicity or progressive disease, patient will be removed from the study and followed until progression and for survival.
If the patient has Grade 3 or 4 neurotoxicity and/or the creatinine rises above 2.0, then the cisplatin will be discontinued and the patient continued on study and treated with gemcitabine and bevacizumab at the same dose and schedule.
ECOG Performance Status 0 or 1
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Noah Hahn, M.D. | 317-274-3515 | nhahn@iupui.edu |
Contact: Jayme Harvey | 317-921-2050 | harveyj@iupui.edu |
United States, Illinois | |
University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Walter Stadler, M.D. 773-702-4150 | |
Medical & Surgical Specialists, LLC | Recruiting |
Galesburg, Illinois, United States, 61401 | |
Contact: John McClean, M.D. 309-343-2262 | |
Contact: Linda Ferry, R.N. 309-343-2262 lferry@grics.net | |
United States, Indiana | |
Indiana University Cancer Center | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Christopher Sweeney, M.B.B.S. 317-274-3515 chsweene@iupui.edu | |
Contact: Kerry Bridges 317-274-2552 kdbridge@iupui.edu | |
Fort Wayne Oncology & Hematology, Inc | Recruiting |
Fort Wayne, Indiana, United States, 46815 | |
Contact: Sreenivasa Nattam, M.. 260-484-8830 | |
Contact: Lesllie Edgar, R.N. 260-484-8830 ledgar@fwmoh.com | |
Northern Indiana Cancer Research Consortium | Recruiting |
South Bend, Indiana, United States, 46601 | |
Contact: Robin Zon, M.D. 574-234-5123 | |
Contact: Susan Haithcox, R.N. (574) 647-7977 shaithcox@memorialsb.org | |
Oncology Hematology Associates of SW Indiana | Recruiting |
Evansville, Indiana, United States, 47714 | |
Contact: Michael Titzer, M.D. 812-471-1200 | |
Contact: Paige Wisnoski 812-471-1200 pwisnoski@OHAEV.com | |
AP&S Clinic | Terminated |
Terre Haute, Indiana, United States, 47804 | |
Arnett Cancer Care | Recruiting |
Lafayette, Indiana, United States, 47904 | |
Contact: Thomas Jones, M.D. 765-448-7500 | |
Contact: Janice Welty, R.N. 765-448-7500 weltyj@arnett.com | |
Quality Cancer Center (MCGOP) | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: William Dugan, M.D. 317-927-0825 | |
Contact: Jane Berby-Todd 317-962-6597 jberby@clarian.org | |
United States, Missouri | |
Siteman Cancer Center | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Joel Picus, M.D. 314-747-1367 | |
Contact: Henry Robinson 314-747-1375 hrobinso@im.wustl.edu | |
United States, Ohio | |
Oncology Hematology Care, Inc. | Recruiting |
Cincinnati, Ohio, United States, 45242 | |
Contact: David Waterhouse, M.D. 513-891-4800 | |
Contact: Ann Bradley, R.N. 513-891-4800 abradley@ohcmail.com |
Study Chair: | Christopher Sweeney, M.B.B.S. | Hoosier Oncology Group, LLC |
Responsible Party: | Hoosier Oncology Group ( Noah Hahn, M.D. ) |
Study ID Numbers: | HOG GU04-75 |
Study First Received: | October 5, 2005 |
Last Updated: | July 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00234494 |
Health Authority: | United States: Institutional Review Board |
Cystocele Cisplatin Urologic Diseases Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms |
Bevacizumab Gemcitabine Urologic Neoplasms Urinary tract neoplasm Bladder neoplasm |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Angiogenesis Inhibitors |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |