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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Urologic Neoplasms

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Trial Information

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


Inclusion Criteria:



- Histologic diagnosis of urothelial carcinoma (TCC or Squamous) that is either
metastatic or locally recurrent and not curable by surgery or radiation therapy.

- All patients must have tissue from either the primary or metastatic site tested for
HER2 status determination. Patients with Her-2 negative tumors are not eligible for
treatment on this protocol.

- 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.

- Patients may not have received prior systemic chemotherapy for metastatic disease.
Patients may have received adjuvant chemotherapy if completed at least 6 months prior
to beginning this protocol treatment.

- Patients may not have 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.

Exclusion Criteria:

- Pregnant or lactating women may not participate.

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objective of the study is to evaluate the toxicity profile of combination of herceptin, paclitaxel, carboplatin and gemcitabine in patients with locally recurrent or metastatic urothelial carcinoma who overexpress HER2.

Principal Investigator

Maha Hussain, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Michigan Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

UMCC 9955

NCT ID:

NCT00151034

Start Date:

September 2000

Completion Date:

Related Keywords:

  • Urologic Neoplasms
  • Urothelial Cancer
  • Herceptin
  • Advanced Urothelial Cancer
  • Neoplasms
  • Urologic Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Weill Medical College of Cornell UniversityNew York, New York  10021
University of ColoradoDenver, Colorado  80217
Wayne State UniversityDetroit, Michigan  48202
Columbia Presbyterian Medical CenterNew York, New York  10032
The University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109
California City of Hope National Medical GroupDuarte, California  
U.C. Davis Medical CenterSacramento, California