Trastuzumab in Treating Patients With Previously Treated, Locally Advanced, or Metastatic Cancer of the Urothelium
Stopped early · Phase 2
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT00004856
- Run by
- National Cancer Institute (NCI)
- People needed
- 40
- Starts
- 2002-07-01
- Last updated by the study team
- 2013-05-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Cancer and Leukemia Group B — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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