Urinary Bladder NeoplasmsPhase 2NCT00710970
Tamoxifen for Progressive Transitional Cell Carcinoma Following Previous Chemotherapy Treatment
A Phase 2 study testing Tamoxifen in people with Urinary Bladder Neoplasms, run by Seth Lerner at 2 sites in 2 countries.
Trial summary
The major objective of this two-stage phase II study is to determine whether tamoxifen is deserving of further study in metastatic bladder cancer. Tamoxifen is expected to function as a cytostatic (and not cytotoxic) agent, and may produce more disease stability than regression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Neoplasms
- What is being tested?
- Tamoxifen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2007to Dec 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients previously diagnosed with bladder cancer who have already received 1-2 systemic therapy regimens (chemotherapy or biological therapy or both) but including at least one chemotherapy regimen.
- Patients who have had the cancer spread to other parts of the body.
- Patients must have adequate liver function.
Who cannot join
- Patients who have uncontrolled nervous system metastasis
- Patients who are pregnant
- Patients who have had systemic therapies within the past 4 weeks
- Patients who plan to have major surgery within 2 weeks
- Patients who have Grade III/IV heart problems
- Patients who have severe and/or uncontrolled medical disease.
- Patients who might be at high risk for deep vein thrombosis
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: H-16848 - Phase II Pilot Study With Correlative Markers of Tamoxifen for Progressive Transitional Cell Carcinoma Following Previous Chemotherapy
The major objective of this two-stage phase II study is to determine whether tamoxifen is deserving of further study in metastatic bladder cancer. Tamoxifen is expected to function as a cytostatic (and not cytotoxic) agent, and may produce more disease stability than regression. Sustained stable disease is considered to be clinically important and the more likely event. Hence, 4-month freedom from progression is chosen as the primary end-point instead of response rate. Freedom from progression is defined as the period from start of therapy to the time of objective radiologic progression. A total of 25 subjects will be enrolled, 15 during stage 1 and 10 during stage 2 of a two-stage minimax design phase II study.
Pre-therapy evaluation (within 3 weeks of initiation of therapy):
Read more
- History and physical examination (H and P)
- Performance status (PS) assessment
- CBC (complete blood counts)
- CMP (complete metabolic profile)
- Pregnancy test (in women younger than 50)
- Computed tomography (CT) scan of the chest, abdomen and pelvis
- Bone scan if bone pain or raised alkaline phosphatase
- Biopsy (may use previous biopsy specimen)
- Samples of plasma from the routine CBC and CMP will be banked indefinitely for future biomarker studies at the Scott Department of Urology.
Treatment plan: Therapy will be administered as an outpatient. Tamoxifen is administered at 20 mg/day as a single daily oral dose. Clinical assessment of patients by a history and physical examination will be performed every 4 weeks (one cycle). Objective radiological assessment of response will be made every 8 weeks or earlier if clinically indicated. A CT (computerized tomography) scan of the abdomen, pelvis and chest will be performed at baseline and every 2 cycles. A response is confirmed by repeating the scans in 4 weeks. Bone scan is performed if the patient complains of new bone pain or has raised alkaline phosphatase. A radiologist who is blinded to the treatment regimen reads the scans. The RECIST criteria are used to define response. Tamoxifen is continued until progressive disease or intolerable side effects occur.
- Conditions
- Urinary Bladder Neoplasms
- Being tested
- Tamoxifen
- Keywords
- Urinary Bladder Neoplasms, Previous Chemotherapy, Tamoxifen, Anti-tumor activity
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
Also called raloxifene
Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Receiving 25mg Tamoxifen | Experimental | Not described Receives: Drug: Tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Freedom From Progression of Cancer at 4 Months
Clinical Assessments were performed every 4 weeks and imaging every 8 weeks or earlier if indicated.
Patients were followed every month for clinical symptoms and signs of progression.
Patients underwent Radiographic CT scans every 8 weeks to look for progression.
Measured: Estimated from date of starting therapy until 4 months but up to progression or death which ever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seth Lerner
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Cytogen Corporation
- Responsible party
- Sponsor-investigator, Seth Lerner, Baylor College of Medicine
- Investigators
- Seth P. Lerner, M.D., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710970
- Sponsor's protocol ID
- H-16848
- Status last verified
- Jan 2022
- First submitted
- 7 Jul 2008
- Last updated
- 24 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kim HT, Kim BC, Kim IY, Mamura M, Seong DH, Jang JJ, Kim SJ. Raloxifene, a mixed estrogen agonist/antagonist, induces apoptosis through cleavage of BAD in TSU-PR1 human cancer cells. J Biol Chem. 2002 Sep 6;277(36):32510-5. doi: 10.1074/jbc.M202852200. Epub 2002 Jun 25.
PubMed 12084714Shen SS, Smith CL, Hsieh JT, Yu J, Kim IY, Jian W, Sonpavde G, Ayala GE, Younes M, Lerner SP. Expression of estrogen receptors-alpha and -beta in bladder cancer cell lines and human bladder tumor tissue. Cancer. 2006 Jun 15;106(12):2610-6. doi: 10.1002/cncr.21945.
PubMed 16700038
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- H-16848 - Phase II Pilot Study With Correlative Markers of Tamoxifen for Progressive Transitional Cell Carcinoma Following Previous Chemotherapy
- ClinicalTrials.gov ID
- NCT00710970
- Acronym / sponsor ID
- H-16848
- Conditions
- Urinary Bladder Neoplasms
- Keywords
- Urinary Bladder Neoplasms, Previous Chemotherapy, Tamoxifen, Anti-tumor activity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Seth LernerUniversity, hospital or other
- Collaborators
- AstraZeneca, Cytogen Corporation
- Study start
- Jan 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Jul 2008 (estimated)
- Results
- Posted 22 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The major objective of this two-stage phase II study is to determine whether tamoxifen is deserving of further study in metastatic bladder cancer. Tamoxifen is expected to function as a cytostatic (and not cytotoxic) agent, and may produce more disease stability than regression. Sustained stable disease is considered to be clinically important and the more likely event. Hence, 4-month freedom from progression is chosen as the primary end-point instead of response rate. Freedom from progression is defined as the period from start of therapy to the time of objective radiologic progression. A total of 25 subjects will be enrolled, 15 during stage 1 and 10 during stage 2 of a two-stage minimax design phase II study.
Pre-therapy evaluation (within 3 weeks of initiation of therapy):
- History and physical examination (H and P)
- Performance status (PS) assessment
- CBC (complete blood counts)
- CMP (complete metabolic profile)
- Pregnancy test (in women younger than 50)
- Computed tomography (CT) scan of the chest, abdomen and pelvis
- Bone scan if bone pain or raised alkaline phosphatase
- Biopsy (may use previous biopsy specimen)
- Samples of plasma from the routine CBC and CMP will be banked indefinitely for future biomarker studies at the Scott Department of Urology.
Treatment plan: Therapy will be administered as an outpatient. Tamoxifen is administered at 20 mg/day as a single daily oral dose. Clinical assessment of patients by a history and physical examination will be performed every 4 weeks (one cycle). Objective radiological assessment of response will be made every 8 weeks or earlier if clinically indicated. A CT (computerized tomography) scan of the abdomen, pelvis and chest will be performed at baseline and every 2 cycles. A response is confirmed by repeating the scans in 4 weeks. Bone scan is performed if the patient complains of new bone pain or has raised alkaline phosphatase. A radiologist who is blinded to the treatment regimen reads the scans. The RECIST criteria are used to define response. Tamoxifen is continued until progressive disease or intolerable side effects occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Receiving 25mg Tamoxifen | Experimental | Drug: Tamoxifen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients previously diagnosed with bladder cancer who have already received 1-2 systemic therapy regimens (chemotherapy or biological therapy or both) but including at least one chemotherapy regimen.
- Patients who have had the cancer spread to other parts of the body.
- Patients must have adequate liver function.
Key exclusion criteria (7 listed)
- Patients who have uncontrolled nervous system metastasis
- Patients who are pregnant
- Patients who have had systemic therapies within the past 4 weeks
- Patients who plan to have major surgery within 2 weeks
- Patients who have Grade III/IV heart problems
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 |
|---|---|---|
| TamoxifenAlso: raloxifeneTamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen. | Drug | Single Arm Receiving 25mg Tamoxifen |
Primary outcome
Number of Participants With Freedom From Progression of Cancer at 4 Months
Time frame: Estimated from date of starting therapy until 4 months but up to progression or death which ever comes first.
Clinical Assessments were performed every 4 weeks and imaging every 8 weeks or earlier if indicated. Patients were followed every month for clinical symptoms and signs of progression. Patients underwent Radiographic CT scans every 8 weeks to look for progression.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12084714Kim HT, Kim BC, Kim IY, Mamura M, Seong DH, Jang JJ, Kim SJ. Raloxifene, a mixed estrogen agonist/antagonist, induces apoptosis through cleavage of BAD in TSU-PR1 human cancer cells. J Biol Chem. 2002 Sep 6;277(36):32510-5. doi: 10.1074/jbc.M202852200. Epub 2002 Jun 25.
- Background: PubMed 16700038Shen SS, Smith CL, Hsieh JT, Yu J, Kim IY, Jian W, Sonpavde G, Ayala GE, Younes M, Lerner SP. Expression of estrogen receptors-alpha and -beta in bladder cancer cell lines and human bladder tumor tissue. Cancer. 2006 Jun 15;106(12):2610-6. doi: 10.1002/cncr.21945.
- Scott Department of Urology, Baylor College of MedicineLink provided by the sponsor.
- Bladder Cancer Advocacy NetworkLink provided by the sponsor.
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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.
Seth P. Lerner, M.D. principal investigator
Baylor College of Medicine
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tamoxifen in people with Urinary Bladder Neoplasms, run by Seth Lerner at 2 sites in 2 countries.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Italy. 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?
Yes. Results are posted in the registry (first posted 22 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Freedom From Progression of Cancer at 4 Months (time frame: Estimated from date of starting therapy until 4 months but up to progression or death which ever comes first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00710970, which also lists 2 linked publications.
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 24 Jan 2022.