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

Primary Purpose

Distal Urethral Cancer, Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter, Proximal Urethral Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
trastuzumab
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Urethral Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer and Leukemia Group B

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment: Herceptin

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Toxicities as graded according to the NCI Common Toxicity Criteria
Proportion of patients who are HER2 positive (3+ by IHC or FISH positive)
Overall survival (OS)
Disease-free survival (DFS)

Full Information

First Posted
March 7, 2000
Last Updated
May 1, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004856
Brief Title
Trastuzumab in Treating Patients With Previously Treated, Locally Advanced, or Metastatic Cancer of the Urothelium
Official Title
A Phase II Trial of Trastuzumab (Herceptin; NSC #688097, IND #6667) in Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Terminated
Study Start Date
July 2002 (undefined)
Primary Completion Date
July 2002 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment: Herceptin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
trastuzumab
Other Intervention Name(s)
anti-c-erB-2, Herceptin, MOAB HER2
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Objective response rate (complete or partial response) as assessed by RECIST criteria
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Toxicities as graded according to the NCI Common Toxicity Criteria
Time Frame
12 weeks
Title
Proportion of patients who are HER2 positive (3+ by IHC or FISH positive)
Time Frame
Baseline
Title
Overall survival (OS)
Time Frame
From date of initiation of treatment to date of death due to any cause, assessed up to 1 year
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arif Hussain
Organizational Affiliation
Cancer and Leukemia Group B
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer and Leukemia Group B
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60606
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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