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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004856
First received: March 7, 2000
Last updated: May 1, 2013
Last verified: May 2013
  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. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.


Condition Intervention Phase
Distal Urethral Cancer
Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
Proximal Urethral Cancer
Recurrent Bladder Cancer
Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
Recurrent Urethral Cancer
Stage IV Bladder Cancer
Transitional Cell Carcinoma of the Bladder
Urethral Cancer Associated With Invasive Bladder Cancer
Biological: trastuzumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Trastuzumab (Herceptin; NSC #688097, IND #6667) 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):

Primary Outcome Measures:
  • Objective response rate (complete or partial response) as assessed by RECIST criteria [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicities as graded according to the NCI Common Toxicity Criteria [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of patients who are HER2 positive (3+ by IHC or FISH positive) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: From date of initiation of treatment to date of death due to any cause, assessed up to 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: July 2002
Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • anti-c-erB-2
  • Herceptin
  • MOAB HER2

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004856

Locations
United States, Illinois
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606
Sponsors and Collaborators
Investigators
Principal Investigator: Arif Hussain Cancer and Leukemia Group B
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004856     History of Changes
Other Study ID Numbers: NCI-2011-02046, CALGB 90101, UCSF-99535, CALGB-90101, CDR0000067476, NCI-T99-0108, U10CA031946
Study First Received: March 7, 2000
Last Updated: May 1, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014