Bladder CancerPhase 1SOGUG-07-01NCT00544609
Sorafenib and Radiotherapy in the Treatment of Invasive Bladder Cancer With Conservative Intent
A Phase 1 study testing Sorafenib and Radiotherapy in people with Bladder Cancer, run by Spanish Oncology Genito-Urinary Group at 3 sites in Spain.
Trial summary
Safety profile and to determine maximum tolerated dose of Sorafenib in combination with Radiotherapy in the Treatment of Invasive Bladder Cancer With Conservative Intent Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Sorafenib and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesSpain
- Study dates
- Dec 2007to May 2012
- Phase
- Phase 1
- 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
- Patients diagnosed with urothelial carcinoma of the bladder, in clinical stages T2-4a N0 M0 (if multifocal evaluation of all lesions by biopsies), who are not candidates for radical cystectomy by medical reasons or refusal.
- No prior treatment with radiotherapy to the bladder or systemic chemotherapy.
- Patients must be ≥ 18 years old.
- Patients must have ECOG performance status 0 to 2.
- Life expectancy of at least 12 weeks.
- Patients with adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
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- hemoglobin ≥ 9.0 g/dl absolute neutrophil count ≥ 1.500/mm3 platelets ≥ 100.000/mm3. total bilirubin ≤ 1.5 times the upper limit of normality SGOT (AST) and/or SGPT (ALT) ≤ 2.5 times the upper limit of normality alkaline phosphatase ≤ 4 x ULN serum creatinine ≤1.5 upper limit of normality PT-INR/PTT < 1.5 x upper limit of normality creatinine clearance ≥ 40 ml/min using Cockcroft-Gaul
- Patients must give their written informed consent before any procedure related to the study is performed; therefore, it must be given at the selection visit. The patient must be informed that he has the right to withdraw from the study at any time, without any kind of prejudice.
- Patients who are capable of accomplishing the study's requirements and without any impediments to follow the instructions.
- Women of fertile age must have a negative result in the pregnancy test performed 7 days before the beginning of the administration of the study medication.
- Patients from both sexes must use adequate contraceptive methods (oral or injectable contraceptives, intrauterine device, condom, sterilization) whilst participating in the protocol. After the retreat of treatment with sorafenib, the contraceptive methods must be used during 4 weeks in women and during 3 months in men.
Who cannot join
- Patients with active infection or other serious medical conditions (autologous bone marrow transplant or stem cell rescue within 4 months of study, patients undergoing renal dialysis, known HIV infection or chronic hepatitis B or C, active clinically serious infections > CTCAE Grade 2, non-healing wound, ulcer, or bone fracture).
- Abuse of substances, clinical conditions, psychological or social, that would preclude appropriate informed consent or compliance with protocol.
- Concurrent treatment with other experimental drugs (within 30 days prior to study entry).
- Concurrent treatment with other anti-cancer- or immunotherapy during the study or within 4 weeks of study entry.
- Treatment wuth mitomycin C or nitrosureas during 6 weeks prior of study entry.
- History of prior malignancies within the preceding 5 years other than previously treated basal cell carcinoma of the skin, incipient prostate cancer and in situ cervix carcinoma.
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- Pregnant or breast feeding patients.
- Known or suspected allergy to sorafenib.
- Cardiac disease: Congestive heart failure > class II NYHA; active CAD (myocardial infarction more than 6 months to study entry is allowed); cardiac arrythmias requiring anti-arrythmic therapy (beta blockers or digoxin are permitted).
- Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal medical management.
- Known brain metastasis. Patients with neurological symptoms should undergo a CT scan/MRI of the brain to exclude brain metastasis.
- Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months.
- Patients with hydronephrosis.
- Patients with seizure disorder requiring medication (such as steroids or antiepileptics).
- History of organ allograft.
- Patient unable to swallow oral medication.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Clínic i Provincial de Barcelona
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
Institut Català d' Oncología
Barcelona
About this study
Official title: Phase I Trial of Sorafenib in Combination With Radiotherapy in the Treatment of Invasive Bladder Cancer With Conservative Intent
Safety profile and to determine maximum tolerated dose of Sorafenib in combination with Radiotherapy in the Treatment of Invasive Bladder Cancer With Conservative Intent
Read the detailed description
Study phase I in patients with Invasive Bladder Cancer
- Conditions
- Bladder Cancer
- Being tested
- Sorafenib, Radiotherapy
- Keywords
- Bladder, Sorafenib, Radiotherapy
- 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.
SorafenibDrug
Also called Nexavar
Level 1: 200 mg/day Level 2: 400mg/day Level 3: 800mg/day
RadiotherapyProcedure or surgery
Also called Sorafenib, Nexavar
3th-8th week: sorafenib daily with radiotherapy day 1, 2, 3, 4 and 5, 9th week: sorafenib daily with radiotherapy day 1 and 2
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib | Other | 2 weeks:Sorafenib, 6 weeks and a half:Sorafenib with radiotherapy, 4 weeks:Sorafenib Receives: Drug: Sorafenib; Procedure: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile of Sorafenib in combination with Radiotherapy.
Measured: 12 weeks
Maximum tolerated dose of Sorafenib in combination with Radiotherapy.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startDec 2007
- Primary completionAug 2010
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Oncology Genito-Urinary Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier García del Muro Solans, MD, Study chair, Institut Català d' Oncología, BarcelonaSalvador Villà Freixa, MD, Study chair, Institut Català d' Oncología, Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544609
- Sponsor's protocol ID
- SOGUG-07-01
- Acronym
- SOGUG-07-01
- Status last verified
- Oct 2014
- First submitted
- 15 Oct 2007
- Last updated
- 2 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Sorafenib in Combination With Radiotherapy in the Treatment of Invasive Bladder Cancer With Conservative Intent
- ClinicalTrials.gov ID
- NCT00544609
- Acronym / sponsor ID
- SOGUG-07-01 / SOGUG-07-01
- Conditions
- Bladder Cancer
- Keywords
- Bladder, Sorafenib, Radiotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Spanish Oncology Genito-Urinary GroupUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 16 Oct 2007 (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.
Safety profile and to determine maximum tolerated dose of Sorafenib in combination with Radiotherapy in the Treatment of Invasive Bladder Cancer With Conservative Intent
Detailed description
Study phase I in patients with Invasive Bladder Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib | Other | Drug: Sorafenib, Procedure: Radiotherapy2 weeks:Sorafenib, 6 weeks and a half:Sorafenib with radiotherapy, 4 weeks:Sorafenib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients diagnosed with urothelial carcinoma of the bladder, in clinical stages T2-4a N0 M0 (if multifocal evaluation of all lesions by biopsies), who are not candidates for radical cystectomy by medical reasons or refusal.
- No prior treatment with radiotherapy to the bladder or systemic chemotherapy.
- Patients must be ≥ 18 years old.
- Patients must have ECOG performance status 0 to 2.
- Life expectancy of at least 12 weeks.
Key exclusion criteria (16 listed)
- Patients with active infection or other serious medical conditions (autologous bone marrow transplant or stem cell rescue within 4 months of study, patients undergoing renal dialysis, known HIV infection or chronic hepatitis B or C, active clinically serious infections > CTCAE Grade 2, non-healing wound, ulcer, or bone fracture).
- Abuse of substances, clinical conditions, psychological or social, that would preclude appropriate informed consent or compliance with protocol.
- Concurrent treatment with other experimental drugs (within 30 days prior to study entry).
- Concurrent treatment with other anti-cancer- or immunotherapy during the study or within 4 weeks of study entry.
- Treatment wuth mitomycin C or nitrosureas during 6 weeks prior of study entry.
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 |
|---|---|---|
| SorafenibAlso: NexavarLevel 1: 200 mg/day Level 2: 400mg/day Level 3: 800mg/day | Drug | Sorafenib |
| RadiotherapyAlso: Sorafenib, Nexavar3th-8th week: sorafenib daily with radiotherapy day 1, 2, 3, 4 and 5, 9th week: sorafenib daily with radiotherapy day 1 and 2 | Procedure or surgery | Sorafenib |
Primary outcome
Safety profile of Sorafenib in combination with Radiotherapy.
Time frame: 12 weeks
Maximum tolerated dose of Sorafenib in combination with Radiotherapy.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
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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.
Xavier García del Muro Solans, MD study chair
Institut Català d' Oncología, Barcelona
Salvador Villà Freixa, MD study chair
Institut Català d' Oncología, Barcelona
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sorafenib and Radiotherapy in people with Bladder Cancer, run by Spanish Oncology Genito-Urinary Group at 3 sites in Spain.
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 11 inclusion and 16 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 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety profile of Sorafenib in combination with Radiotherapy. (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 2 Oct 2014.