Study of Gemcitabine and Cisplatin With or Without Cetuximab in Urothelial Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Comprehensive Cancer Network
Bristol-Myers Squibb
ImClone LLC
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00645593
First received: March 24, 2008
Last updated: May 11, 2013
Last verified: May 2013
  Purpose

This study will compare the effects, good and/or bad, of chemotherapy (Gemcitabine and Cisplatin) with or without the addition of the chemotherapy drug Cetuximab to find out which treatment is better.


Condition Intervention Phase
Bladder Cancer
Drug: Gemcitabine, Cisplatin
Drug: Gemcitabine, Cisplatin and Cetuximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Randomized Trial of Gemcitabine and Cisplatin With or Without Cetuximab in Patients With Urothelial Carcinoma

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • To compare the overall response rate of combination gemcitabine and cisplatin with or without cetuximab in patients with locally advanced or metastatic urothelial carcinoma [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety and tolerability, response duration, the progression-free survival and overall survival of both treatment groups, and whether cetuximab will sensitize non-responding patients to combination gemcitabine and cisplatin. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 89
Study Start Date: March 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1, Gemcitabine and Cisplatin
Gemcitabine and Cisplatin, as described in the intervention
Drug: Gemcitabine, Cisplatin
Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
Other Name: Gemzar
Experimental: Arm 2, Cetuximab, Gemcitabine and Cisplatin
Gemcitabine and Cisplatin with Cetuximab, as described in the intervention
Drug: Gemcitabine, Cisplatin and Cetuximab
Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
Other Name: Erbitux

Detailed Description:

Urothelial cancer typically begins in the lining of the bladder, the balloon-shaped organ in the pelvic area that stores urine. Urothelial cancer can also begin in the ureter (the tube connecting the kidney and bladder), part of the kidney itself, or the urethra (the tube you pass urine out of). Some Urothelial cancers remain confined to the lining, while in other cases they spread to other areas. Treatment for these cancers varies greatly depending on the stage of disease at the time of diagnosis. Study participants in this research study will have a diagnosis of urothelial cancer that is advanced or has come back after prior therapy.

There are two standard chemotherapeutic regimens for the management of this disease. One is the combination of the drugs, methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC). However the toxicities associated with this treatment regimen (side effects) is high.

The other is a combination of two drugs called Cisplatin and Gemcitabine. These drugs are also known to destroy urothelial cancer cells, and are better tolerated by patients. All study participants will receive both of these drugs.

Another anti-cancer drug called Cetuximab is known to delay or prevent tumor growth and in some cases to lead to death of cancer cells by blocking certain cellular pathways that lead to tumor development. This drug has been approved by the United States Food and Drug Administration (FDA) for the treatment of colorectal cancer and for treatment of head and neck cancers. The use of Cetuximab for the treatment of urothelial cancer is investigational in this study.

The purpose of this study is to compare the safety and efficacy of Gemcitabine and Cisplatin administered with or without the addition of Cetuximab in study participants with urothelial cancer.

This is a randomized research study. Study participants will be randomized to receive either gemcitabine and cisplatin alone or in combination with Cetuximab.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Study participants will be male or female at least 18 years of age
  • Study participants will have a histologic/cytologic diagnosis of urothelial carcinoma (transitional cell carcinoma; either pure or mixed histology) that is metastatic, locally recurrent, or unresectable (T4bN0 or any T, N2030)
  • Study participants must have measurable disease by radiologic imaging. Study participants that have received previous radiation therapy, recovered from side effects and have not had more than 25% of the bone marrow
  • Study participants must have adequate bone marrow function

Exclusion Criteria:

  • Study participants may not have received previous systemic chemotherapy for the current stage of disease with the following exception: prior neoadjuvant or adjuvant chemotherapy is allowed provided it has been at least 6 months since treatment with non-cisplatin containing regimens and > 1 year since treatment with a cisplatin containing regimen
  • Study participants may not have received prior therapy targeting the EGFR pathway
  • Study participants may not have a history or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan
  • Study participants may not have known HIV due to the intense nature of the chemotherapy in this trial
  • Study subjects may not have a history of congestive heart failure (CHF), chronic renal failure, active TIAs, recent (in the last 6 months) stroke, symptomatic pulmonary embolism (PE), or myocardial infarction.
  • Study participants with history of DVT or incidental or asymptomatic PE will be eligible for the study as deemed appropriate by the treating physician provided they continue prophylactic or full dose anticoagulation as per standards of care for the specific event.
  • Study participants must not have a prior grade 3 or 4 severe infusion reaction to monoclonal antibodies
  • Study participants may not be pregnant or breastfeeding
  • Study participants may not receive concurrent treatment on another therapeutic clinical trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645593

Locations
United States, California
City of Hope Cancer Center
Duarte, California, United States, 91010
Kenneth J. Norris Jr. Comprehensive Cancer Center, Keck School of Medicine, University of Southern California
Los Angeles, California, United States, 90033
Stanford University
Stanford, California, United States, 94305
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Center of Northwestern University
Chicago, Illinois, United States, 60611
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-3721
United States, Utah
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Washington
University of Washington
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Michigan Cancer Center
National Comprehensive Cancer Network
Bristol-Myers Squibb
ImClone LLC
Investigators
Principal Investigator: Maha Hussain, M.D. University of Michigan
  More Information

No publications provided by University of Michigan Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00645593     History of Changes
Other Study ID Numbers: UMCC 2007.097
Study First Received: March 24, 2008
Last Updated: May 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan Cancer Center:
Bladder Cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Cetuximab
Cisplatin
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014