AzTrials
AzTrials

Metastatic Transitional Cell Cancer of the Renal Pelvis and UreterPhase 2NCT00005831

Trastuzumab and Combination Chemotherapy in Treating Patients With Locally Recurrent or Metastatic Urinary Tract Cancer

A Phase 2 study testing trastuzumab, paclitaxel and carboplatin in people with Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter and Recurrent Bladder Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

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

Official record
Search all trials

Trial summary

Phase II trial to study the effectiveness of combining trastuzumab with combination chemotherapy in treating patients who have locally recurrent or metastatic urinary tract cancer. Read more about this study

Who is it for?
Any age
What is being tested?
trastuzumab, paclitaxel and carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
Mar 2000to Aug 2004
Phase
Phase 2
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologic diagnosis of urothelial carcinoma (TCC or Squamous) that is either metastatic or locally recurrent and not curable by surgery or radiation therapy; patients must have HER2 overexpression as documented by ANY of the following: 1. 2+ or 3+ staining by immunohistochemistry, or 2. a positive FISH score defined as > 2 with the Vysis system or > 4 with the Ventana system, or 3. an elevated serum HER2 of > 16 ng/ml using the OSDI assay; please note:
  • Tissue from either the primary or metastatic site must be tested for HER2 status determination
  • All patients must have a blood sample drawn for HER2 serologic testing
  • If the available tissue is from the primary tumor and is HER2 negative and if the serum is negative, to qualify for the study a biopsy of a metastatic site should be done and the patient will be eligible ONLY if this demonstrates HER2 over-expression
  • All sites and measurements of disease must be clearly documented in the pre-study forms
  • All prior local or adjuvant systemic therapy including the type of chemotherapy must be clearly documented in the pre-study form Note: Patients with Her-2 negative tumors are not eligible for treatment on this protocol but their response to other therapy and survival will also be evaluated
Show all 24Show fewer
  • Bidimensionally measurable or evaluable disease not previously radiated
  • No prior systemic chemotherapy for metastatic disease; patients may have received adjuvant chemotherapy if completed at least 6 months prior to beginning this protocol treatment; type and number of courses of prior chemotherapy must be clearly documented
  • A performance status of 0-2 by Southwest Oncology Group criteria and a life expectancy of greater than 12 weeks
  • Serum creatinine =< 2.0 mg%
  • Granulocyte count >= 1,500/mm^3
  • Platelet >= 100,000/mm^3
  • Total bilirubin =< 1.5 mg/dl
  • No significant cardiac disease and must have adequate cardiac function (ejection fraction >= 50% or higher than the lower limit of institutional normal) as determined by a MUGA scan or 2-D echocardiogram within 4 weeks from registration, and no evidence of symptomatic coronary artery disease (baseline EKG must show no active ischemia); patients must not have history of congestive heart failure
  • If patients have received prior radiation therapy, disease must be present outside of radiated fields and at least 4 weeks must have elapsed since discontinuation of that therapy; the nadirs of RT leukopenia and thrombocytopenia must be surpassed with evidence of hematologic recovery
  • No prior malignancy is allowed, except for adequately treated basal cell (or squamous cell) skin cancer, in situ carcinoma of any site or other cancer for which the patient is currently disease free
  • Patient may not have unresolved bacterial infection
  • Pregnant or lactating women may not participate; this is to avoid potential harm since the effects of study drugs on the fetus or the nursing infant are not known; women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
  • HIV -positive patients may not participate; this is to avoid additional complications that immune suppression and HIV infection may cause due to the intense nature of the chemotherapy in this trial
  • Timing guidelines for pre-study labs (excluding HER2 determination) and measurements;
  • To be completed within 14 days prior to registration; pre-study labs required for determination of eligibility
  • To be completed within 28 days prior to registration: x-rays, scans or physical examination used for tumor
  • All patients must be informed of the investigational nature of this study and must sign an informed consent in accordance with institutional and federal guidelines
  • All patients must be registered with the UM Cancer Center Clinical Trials Office at 734-647-8174 (Joanne Goodson) prior to instituting therapy

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan University Hospital

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Phase II Evaluation of Trastuzumab (Herceptin), Paclitaxel, Carboplatin, and Gemcitabine in the Treatment of Advanced Urothelial Cancer

Phase II trial to study the effectiveness of combining trastuzumab with combination chemotherapy in treating patients who have locally recurrent or metastatic urinary tract cancer. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with combination chemotherapy may kill more tumor cells

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the toxicity of the combination of Herceptin, paclitaxel, carboplatin, and gemcitabine in patients with metastatic or locally recurrent urothelial cancers who overexpress HER2.

SECONDARY OBJECTIVES:

  1. The complete and partial response rates. II. The median and overall survival. III. To prospectively evaluate the percentage of patients with metastatic/recurrent bladder cancer who overexpress HER2 histologically (by immunohistochemistry and FISH) and serologically.

IV. To generate preliminary data on response to other therapy and survival for Her2 negative patients.

OUTLINE:

Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15; paclitaxel IV over 3 hours and carboplatin IV over 15 minutes on day 1; and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 3 weeks. Patients achieving a complete response (CR) receive 3 courses past CR. Patients achieving a partial response or stable disease continue on therapy until CR or disease progression or unacceptable toxicity.

Patients are followed for disease progression and survival. Patients with HER2-negative disease are not eligible for treatment but are followed every 6 months for response and survival.

Being tested
trastuzumab, paclitaxel, carboplatin, gemcitabine hydrochloride, laboratory biomarker analysis
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.

  • trastuzumabBiological

    Also called anti-c-erB-2, Herceptin, MOAB HER2

    Given IV

  • paclitaxelDrug

    Also called Anzatax, Asotax, TAX, Taxol

    Given IV

  • carboplatinDrug

    Also called Carboplat, CBDCA, JM-8, Paraplat

    Given IV

  • gemcitabine hydrochlorideDrug

    Also called dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00005831
Study groupRoleWhat they receive
Treatment (trastuzumab, combination chemotherapy)ExperimentalPatients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15; paclitaxel IV over 3 hours and carboplatin IV over 15 minutes on day 1; and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 3 weeks. Patients achieving a complete response (CR) receive 3 courses past CR. Patients achieving a partial response or stable disease continue on therapy until CR or disease progression or unacceptable toxicity.
Receives: Biological: trastuzumab; Drug: paclitaxel; Drug: carboplatin; Drug: gemcitabine hydrochloride; Other: laboratory biomarker analysis

What is being measured

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

  1. Cardiac toxicity rate of this combination using MUGA or 2D ECHO

    Measured: Up to 7 years

  2. Response rate

    The response rate of this regimen will be estimated with a standard error no greater than 7.9%.

    Measured: Up to 7 years

Secondary outcomes (2)

  1. Time to disease progression

    Kaplan-Meier method will be used for the analysis and graphic presentation of this data.

    Measured: Up to 7 years

  2. Survival duration

    Kaplan-Meier method will be used for the analysis and graphic presentation of this data.

    Measured: Up to 7 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 Jan 2003 (estimated)
  2. Study startMar 2000
  3. Primary completionAug 2004

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005831
Sponsor's protocol ID
NCI-2012-03187
Other IDs
UMCC-9955, U01CA062487, N01CM17101, CDR0000067845
Status last verified
Jan 2013
First submitted
2 Jun 2000
Last updated
14 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing trastuzumab, paclitaxel and carboplatin in people with Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter and Recurrent Bladder Cancer, run by National Cancer Institute (NCI) at 1 site 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 24 inclusion and 0 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 14 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Cardiac toxicity rate of this combination using MUGA or 2D ECHO (time frame: Up to 7 years). The study lists 2 primary outcomes in all. 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 NCT00005831.

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 14 Jan 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in