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


Phase 2
18 Years
N/A
Not Enrolling
Both
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

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective response rate (complete or partial response) as assessed by RECIST criteria

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Arif Hussain

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-02046

NCT ID:

NCT00004856

Start Date:

July 2002

Completion Date:

Related Keywords:

  • 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
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell
  • Urethral Neoplasms
  • Kidney Neoplasms
  • Ureteral Neoplasms

Name

Location

Cancer and Leukemia Group BChicago, Illinois  60606