Trastuzumab in Treating Patients With Previously Treated, Locally Advanced, or Metastatic Cancer of the Urothelium

May 1, 2013 updated by: National Cancer Institute (NCI)

A Phase II Trial of Trastuzumab (Herceptin; NSC #688097, IND #6667) in Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma

Phase II trial to study the effectiveness of trastuzumab in treating patients who have previously treated, locally advanced, or metastatic cancer of the urothelium. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

I. Determine the response rate in patients with previously treated, locally advanced or metastatic transitional cell carcinoma of the urothelium treated with trastuzumab (Herceptin).

II. Determine the safety of this drug in this patient population. III. Determine overall and progression-free survival of this patient population treated with this drug.

OUTLINE:

Patients receive a loading dose of trastuzumab (Herceptin) IV over 90 minutes on day 1 of week 1. For all subsequent doses, patients receive trastuzumab IV over 30 minutes weekly. Treatment may continue for more than 1 year in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 1 year and then every 6 months thereafter.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60606
        • Cancer and Leukemia Group B

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed transitional cell carcinoma (TCC) of the urothelium, including the bladder, urethra, ureter, or renal pelvis

    • No pure adenocarcinomas, pure squamous cell carcinomas, small cell carcinoma, or only small foci of TCC (less than 10% of tumor specimen)
    • Locally advanced (T4b) TCC of the bladder
    • Metastatic (N2 or N3 or M1)TCC of the urothelium
    • HER2 expression (3+) as determined by immunohistochemistry or gene amplification by fluorescent in situ hybridization
  • Must not be a candidate for potentially curative surgery or radiotherapy

  • Measurable disease

    • At least 1 unidimensionally measurable lesion of at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

    • The following lesions are considered nonmeasurable:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Lymphangitis cutis/pulmonis
      • Abdominal masses not confirmed and followed by imaging techniques
      • Cystic lesions
      • Primary bladder masses

  • Relapsed from or failed to achieve a complete or partial response after 1 prior systemic chemotherapy regimen for TCC, including cisplatin, carboplatin, paclitaxel, docetaxel, or gemcitabine

    • Prior adjuvant or neoadjuvant chemotherapy is considered 1 prior chemotherapy regimen
    • Prior single-agent chemotherapy as a radiosensitizer is not considered a prior systemic chemotherapy regimen
  • No known brain metastases
  • Performance status - CTC 0-2
  • More than 12 weeks
  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 75,000/mm^3
  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST no greater than 2 times ULN
  • Creatinine clearance at least 30 mL/min
  • Ejection fraction at least 50% (or lower limit of normal) by echocardiogram or MUGA
  • No history of ongoing congestive heart failure
  • No active cardiac ischemia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • HIV negative
  • No known autoimmune disease
  • No prior trastuzumab (Herceptin)
  • At least 14 days since prior radiotherapy
  • At least 30 days since prior chemotherapy
  • Prior doxorubicin allowed provided cumulative dose is no greater than 300 mg/m^2
  • Prior epirubicin allowed provided cumulative dose is no greater than 600 mg/m^2
  • No concurrent chemotherapy

  • No concurrent hormonal therapy except:

    • Steroids given for adrenal failure
    • Hormones administered for nondisease-related conditions (e.g., insulin for diabetes)
    • Intermittent dexamethasone as an antiemetic or for sensitivity reactions to study drug
  • No concurrent palliative radiotherapy
  • Prior radiotherapy allowed provided treated area is not only site of measurable disease
  • At least 14 days since prior surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment: Herceptin
Patients receive a loading dose of trastuzumab (Herceptin) IV over 90 minutes on day 1 of week 1. For all subsequent doses, patients receive trastuzumab IV over 30 minutes weekly. Treatment may continue for more than 1 year in the absence of unacceptable toxicity or disease progression.
Biological: trastuzumab
Given IV
Other Names:
  • Herceptin
  • anti-c-erB-2
  • MOAB HER2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (complete or partial response) as assessed by RECIST criteria
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicities as graded according to the NCI Common Toxicity Criteria
Time Frame: 12 weeks
12 weeks
Proportion of patients who are HER2 positive (3+ by IHC or FISH positive)
Time Frame: Baseline
Baseline
Overall survival (OS)
Time Frame: From date of initiation of treatment to date of death due to any cause, assessed up to 1 year
From date of initiation of treatment to date of death due to any cause, assessed up to 1 year
Disease-free survival (DFS)
Time Frame: From date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 1 year
From date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Arif Hussain, Cancer and Leukemia Group B

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Primary Completion (ACTUAL)

July 1, 2002

Study Registration Dates

First Submitted

March 7, 2000

First Submitted That Met QC Criteria

September 29, 2003

First Posted (ESTIMATE)

September 30, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

May 3, 2013

Last Update Submitted That Met QC Criteria

May 1, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2011-02046
  • U10CA031946 (U.S. NIH Grant/Contract)
  • CALGB 90101
  • UCSF-99535
  • CALGB-90101
  • CDR0000067476
  • NCI-T99-0108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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