Trastuzumab in Treating Patients With Previously Treated, Locally Advanced, or Metastatic Cancer of the Urothelium
A Phase II Trial of Trastuzumab (Herceptin; NSC #688097, IND #6667) in Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma
7 other identifiers
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2000
CompletedStudy Start
First participant enrolled
July 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2002
CompletedFirst Posted
Study publicly available on registry
September 30, 2003
CompletedMay 3, 2013
May 1, 2013
Same day
March 7, 2000
May 1, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Objective response rate (complete or partial response) as assessed by RECIST criteria
1 year
Secondary Outcomes (4)
Toxicities as graded according to the NCI Common Toxicity Criteria
12 weeks
Proportion of patients who are HER2 positive (3+ by IHC or FISH positive)
Baseline
Overall survival (OS)
From date of initiation of treatment to date of death due to any cause, assessed up to 1 year
Disease-free survival (DFS)
From date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 1 year
Study Arms (1)
Treatment: Herceptin
EXPERIMENTALPatients 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.
Interventions
Eligibility Criteria
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
- +35 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer and Leukemia Group B
Chicago, Illinois, 60606, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arif Hussain
Cancer and Leukemia Group B
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2000
First Posted
September 30, 2003
Study Start
July 1, 2002
Primary Completion
July 1, 2002
Last Updated
May 3, 2013
Record last verified: 2013-05