Distal Urethral CancerPhase 2NCT00004856
Trastuzumab in Treating Patients With Previously Treated, Locally Advanced, or Metastatic Cancer of the Urothelium
A Phase 2 study testing trastuzumab in people with Distal Urethral Cancer and Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Urethral Cancer, Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter, Proximal Urethral Cancer
- What is being tested?
- trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Jul 2002
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 50Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer and Leukemia Group B
Chicago, Illinois, 60606
About this study
Official title: A Phase II Trial of Trastuzumab (Herceptin; NSC #688097, IND #6667) in Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma
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.
Read the detailed description
OBJECTIVES:
- 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.
- Conditions
- 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
- Being tested
- trastuzumab
- Medical subject headings
- Urinary Bladder Neoplasms, Urethral Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trastuzumabBiological
Also called anti-c-erB-2, Herceptin, MOAB HER2
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment: Herceptin | Experimental | 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. Receives: Biological: trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (complete or partial response) as assessed by RECIST criteria
Measured: 1 year
Secondary outcomes (4)
Toxicities as graded according to the NCI Common Toxicity Criteria
Measured: 12 weeks
Proportion of patients who are HER2 positive (3+ by IHC or FISH positive)
Measured: Baseline
Overall survival (OS)
Measured: From date of initiation of treatment to date of death due to any cause, assessed up to 1 year
Disease-free survival (DFS)
Measured: From date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2003 (estimated)
- Study startJul 2002
- Primary completionJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Urethral CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Arif Hussain, Principal investigator, Cancer and Leukemia Group B
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004856
- Sponsor's protocol ID
- NCI-2011-02046
- Other IDs
- CALGB 90101, UCSF-99535, CALGB-90101, CDR0000067476, NCI-T99-0108, U10CA031946
- Status last verified
- May 2013
- First submitted
- 7 Mar 2000
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Trastuzumab (Herceptin; NSC #688097, IND #6667) in Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00004856
- Acronym / sponsor ID
- NCI-2011-02046
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jul 2002
- Primary completion
- Jul 2002 (actual)
- First posted
- 30 Sep 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment: Herceptin | Experimental | Biological: trastuzumabPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (50 listed)
- Histologically confirmed transitional cell carcinoma (TCC) of the urothelium, including the bladder, urethra, ureter, or renal pelvis
- Must not be a candidate for potentially curative surgery or radiotherapy
- Measurable disease
- 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
- No known brain metastases
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trastuzumabAlso: anti-c-erB-2, Herceptin, MOAB HER2Given IV | Biological | Treatment: Herceptin |
Primary outcome
Objective response rate (complete or partial response) as assessed by RECIST criteria
Time frame: 1 year
4 secondary outcomes
Toxicities as graded according to the NCI Common Toxicity Criteria
Time frame: 12 weeks
Proportion of patients who are HER2 positive (3+ by IHC or FISH positive)
Time frame: Baseline
Overall survival (OS)
Time frame: From date of initiation of treatment to date of death due to any cause, assessed up to 1 year
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
Related trials for Distal Urethral Cancer
Active, not recruitingPhase 2
Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant
Bladder Cancer, Urethral Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arif Hussain principal investigator
Cancer and Leukemia Group B
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing trastuzumab in people with Distal Urethral Cancer and Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 50 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (complete or partial response) as assessed by RECIST criteria (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2013.