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

NCT00645593 | Completed Phase 2 Results DMC

• 1 other identifier: UMCC 2007.097
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Bladder Cancer

Keywords

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants That Respond to Treatment in Arm 1 and Arm 2

  The primary objective is to compare the overall response rate of participants with locally advanced or metastatic urothelial carcinoma treated with gemcitabine and cisplatin with or without cetuximab. Overall response rate is defined as the percentage of participants that experience Complete Response (CR) (Disappearance of all target lesions) or Partial Response (PR) (\>=30% decrease in the sum of the longest diameter of target lesions).

  3 years

Secondary Outcomes (3)

• The Number of Grade 3 to 5 Adverse Events Experienced by Arm 1 and Arm 2

  3 years

• Median Progression-free Survival Time in Months

  3 years

• Median Overall Survival in Months

  3 years

Study Arms (2)

Arm 1, Gemcitabine and Cisplatin

ACTIVE COMPARATOR

Gemcitabine and Cisplatin, as described in the intervention

Drug: Gemcitabine,; Drug: Cisplatin

Arm 2, Cetuximab, Gemcitabine and Cisplatin

EXPERIMENTAL

Gemcitabine and Cisplatin with Cetuximab, as described in the intervention

Drug: Gemcitabine,; Drug: Cisplatin; Drug: Cetuximab

Interventions

Gemcitabine, DRUG

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.

Also known as: Gemzar

Arm 1, Gemcitabine and Cisplatin; Arm 2, Cetuximab, Gemcitabine and Cisplatin

Cisplatin DRUG

Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle.

Arm 1, Gemcitabine and Cisplatin; Arm 2, Cetuximab, Gemcitabine and Cisplatin

Cetuximab DRUG

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.

Also known as: Erbitux

Arm 2, Cetuximab, Gemcitabine and Cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• National Comprehensive Cancer Network: collaborator
• Bristol-Myers Squibb: collaborator
• Eli Lilly and Company: collaborator

Study Sites (14)

City of Hope Cancer Center

Duarte, California, 91010, United States

Location

Kenneth J. Norris Jr. Comprehensive Cancer Center, Keck School of Medicine, University of Southern California

Los Angeles, California, 90033, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Robert H. Lurie Comprehensive Cancer Center, Center of Northwestern University

Chicago, Illinois, 60611, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030-3721, United States

Location

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• Hussain M, Daignault S, Agarwal N, Grivas PD, Siefker-Radtke AO, Puzanov I, MacVicar GR, Levine EG, Srinivas S, Twardowski P, Eisenberger MA, Quinn DI, Vaishampayan UN, Yu EY, Dawsey S, Day KC, Day ML, Al-Hawary M, Smith DC. A randomized phase 2 trial of gemcitabine/cisplatin with or without cetuximab in patients with advanced urothelial carcinoma. Cancer. 2014 Sep 1;120(17):2684-93. doi: 10.1002/cncr.28767. Epub 2014 May 6.

  PMID: 24802654 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Gemcitabine; Cisplatin; Cetuximab

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Maha Hussain, M.D.
• Organization: University of Michigan Comprehensive Cancer Center

mahahuss@umich.edu

(734) 647-8903

Study Officials

• Maha Hussain, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 27, 2008
• Study Start: March 1, 2008
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2015
• Last Updated: May 23, 2016
• Results First Posted: October 27, 2014

Record last verified: 2016-04

Locations

US (14)