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Bladder CancerPhase 2NCT00645593

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

A Phase 2 study testing Gemcitabine,, Cisplatin and Cetuximab in people with Bladder Cancer, run by University of Michigan Rogel Cancer Center at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
Gemcitabine,, Cisplatin and Cetuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
14 sitesUnited States
Study dates
Mar 2008to Jun 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Lahey Clinic

    Burlington, Massachusetts, 01805

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

    Chicago, Illinois, 60611

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • City of Hope Cancer Center

    Duarte, California, 91010

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030-3721

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

    Los Angeles, California, 90033

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • University of Utah Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • University of Washington

    Seattle, Washington, 98109

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

Official title: Phase II Randomized Trial of Gemcitabine and Cisplatin With or Without Cetuximab in Patients With Urothelial Carcinoma

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.

Read the 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.

Conditions
Bladder Cancer
Keywords
Bladder Cancer
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gemcitabine,Drug

    Also called Gemzar

    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.

  • CisplatinDrug

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

  • CetuximabDrug

    Also called Erbitux

    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.

Study groups in NCT00645593
Study groupRoleWhat they receive
Arm 1, Gemcitabine and CisplatinActive comparatorGemcitabine and Cisplatin, as described in the intervention
Receives: Drug: Gemcitabine,; Drug: Cisplatin
Arm 2, Cetuximab, Gemcitabine and CisplatinExperimentalGemcitabine and Cisplatin with Cetuximab, as described in the intervention
Receives: Drug: Gemcitabine,; Drug: Cisplatin; Drug: Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 3 years

Secondary outcomes (3)

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

    One of the secondary outcomes was to assess the safety and tolerability of treatment for both arms.

    The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 were utilized for adverse event reporting.

    Measured: 3 years

  2. Median Progression-free Survival Time in Months

    Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions.

    Measured: 3 years

  3. Median Overall Survival in Months

    Median overall survival in months is provided. One participant who progressed from chemotherapy in arm 1 received cyclophosphamide and achieved long-term disease control therefore there is no upper limit for the 95% confidence interval.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionApr 2014
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00645593
Sponsor's protocol ID
UMCC 2007.097
Status last verified
Apr 2016
First submitted
24 Mar 2008
Last updated
23 May 2016
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24802654

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine,, Cisplatin and Cetuximab in people with Bladder Cancer, run by University of Michigan Rogel Cancer Center at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants That Respond to Treatment in Arm 1 and Arm 2 (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00645593, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2016.

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