Full Text View
Tabular View
No Study Results Posted
Related Studies
Trastuzumab in Treating Patients With Previously Treated, Locally Advanced, or Metastatic Cancer of the Urothelium
This study has been completed.
First Received: March 7, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004856
  Purpose

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of trastuzumab in treating patients who have previously treated, locally advanced, or metastatic cancer of the urothelium.


Condition Intervention Phase
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
Biological: trastuzumab
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Trial of Herceptin in Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 2002
Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the response rate in patients with previously treated, locally advanced or metastatic transitional cell carcinoma of the urothelium treated with trastuzumab (Herceptin).
  • Determine the safety of this drug in this patient population.
  • 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.

PROJECTED ACCRUAL: A total of 13-40 patients will be accrued for this study within 13-18 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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 OR
    • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • CTC 0-2

Life expectancy:

  • More than 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 75,000/mm^3

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST no greater than 2 times ULN

Renal:

  • Creatinine clearance at least 30 mL/min

Cardiovascular:

  • 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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior trastuzumab (Herceptin)

Chemotherapy:

  • See Disease Characteristics
  • 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

Endocrine therapy:

  • 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

Radiotherapy:

  • See Disease Characteristics
  • Prior radiotherapy allowed provided treated area is not only site of measurable disease
  • At least 14 days since prior radiotherapy
  • No concurrent palliative radiotherapy

Surgery:

  • See Disease Characteristics
  • At least 14 days since prior surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004856

Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Arif Hussain, MD University of Maryland Greenebaum Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067476, CALGB-90101, UCSF-99535, NCI-T99-0108
Study First Received: March 7, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004856     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
metastatic transitional cell cancer of the renal pelvis and ureter
recurrent transitional cell cancer of the renal pelvis and ureter
stage IV bladder cancer
recurrent bladder cancer
transitional cell carcinoma of the bladder
urethral cancer associated with invasive bladder cancer
anterior urethral cancer
posterior urethral cancer
recurrent urethral cancer

Study placed in the following topic categories:
Urinary Tract Neoplasm
Kidney Cancer
Cystocele
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Ureteral Diseases
Urogenital Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Recurrence
Carcinoma
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Urethral Cancer
Urethral Neoplasms
Trastuzumab
Neoplasm Metastasis
Bladder Neoplasm
Kidney Diseases
Ureteral Neoplasms
Transitional Cell Carcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Antineoplastic Agents
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Ureteral Diseases
Urogenital Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Urethral Neoplasms
Trastuzumab
Urethral Diseases
Kidney Diseases
Ureteral Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 03, 2009