NCT00005831

Brief 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. 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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2000

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Last Updated

January 14, 2013

Status Verified

January 1, 2013

Enrollment Period

4.4 years

First QC Date

June 2, 2000

Last Update Submit

January 11, 2013

Conditions

Metastatic Transitional Cell Cancer of the Renal Pelvis and UreterRecurrent Bladder CancerRecurrent Transitional Cell Cancer of the Renal Pelvis and UreterSquamous Cell Carcinoma of the BladderStage IV Bladder CancerTransitional Cell Carcinoma of the Bladder

Outcome Measures

Primary Outcomes (2)

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

    Up to 7 years

  • Response rate

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

    Up to 7 years

Secondary Outcomes (2)

  • Time to disease progression

    Up to 7 years

  • Survival duration

    Up to 7 years

Study Arms (1)

Treatment (trastuzumab, combination chemotherapy)

EXPERIMENTAL

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.

Biological: trastuzumabDrug: paclitaxelDrug: carboplatinDrug: gemcitabine hydrochlorideOther: laboratory biomarker analysis

Interventions

trastuzumabBIOLOGICAL

Given IV

Also known as: anti-c-erB-2, Herceptin, MOAB HER2
Treatment (trastuzumab, combination chemotherapy)
paclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol
Treatment (trastuzumab, combination chemotherapy)
carboplatinDRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Treatment (trastuzumab, combination chemotherapy)
gemcitabine hydrochlorideDRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Treatment (trastuzumab, combination chemotherapy)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (trastuzumab, combination chemotherapy)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan University Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

TrastuzumabPaclitaxelTaxesCarboplatinGemcitabine

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesEconomicsHealth Care Economics and OrganizationsCoordination ComplexesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Maha Hussain

    University of Michigan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2000

First Posted

January 27, 2003

Study Start

March 1, 2000

Primary Completion

August 1, 2004

Last Updated

January 14, 2013

Record last verified: 2013-01

Locations

US(1)