Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Trastuzumab (Herceptin), Paclitaxel, Carboplatin and Gemcitabine in Advanced Urothelial Cancer

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00151034
First received: September 6, 2005
Last updated: January 20, 2015
Last verified: January 2015

September 6, 2005
January 20, 2015
September 2000
August 2004   (final data collection date for primary outcome measure)
The Number of Toxicities Experienced by Treated Patients [ Time Frame: 30 Days Post Treatment ] [ Designated as safety issue: Yes ]
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.
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.
Complete list of historical versions of study NCT00151034 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Trastuzumab (Herceptin), Paclitaxel, Carboplatin and Gemcitabine in Advanced Urothelial Cancer
Phase II Evaluation of Trastuzumab (Herceptin), Paclitaxel, Carboplatin, and Gemcitabine in the Treatment of Advanced Urothelial Cancer

Purpose: The purpose of this study is to evaluate the efficacy and safety of treatment with trastuzumab (Herceptin) along with the three other chemotherapy drugs, paclitaxel, carboplatin and gemcitabine, in patients who have advanced urothelial cancer. This clinical trial will also collect information (alternative therapy, response rates, overall survival) from enrolled patients with HER2 negative tumors who are ineligible to receive study treatment.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Urologic Neoplasms
  • Drug: Trastuzumab
    Other Name: Herceptin
  • Drug: Paclitaxel
  • Drug: Carboplatin
  • Drug: Gemcitabine
Experimental: Herceptin

Herceptin - 4mg/kg day 1 of cycle 1; 2mg/kg day 8 and 15 of cycle 1 and subsequent cycles.

Paclitaxel - 200mg/m^2 on day 1 Carboplatin - AUC 5 on day 1 Gemcitabine - 800 mg/m^2 on day 1 and 8

Interventions:
  • Drug: Trastuzumab
  • Drug: Paclitaxel
  • Drug: Carboplatin
  • Drug: Gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
October 2007
August 2004   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00151034
UMCC 9955
Yes
University of Michigan Cancer Center
University of Michigan Cancer Center
Genentech, Inc.
Principal Investigator: Maha Hussain, MD The University of Michigan Comprehensive Cancer Center
University of Michigan Cancer Center
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP