Bladder CancerPhase 1/2GEMCIRAVNCT00556621
Gemcitabine, Cisplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Bladder Cancer
A Phase 1/2 study testing cisplatin, gemcitabine hydrochloride and biopsy in people with Bladder Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. 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?
- cisplatin, gemcitabine hydrochloride and biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2005to Aug 2009
- Phase
- Phase 1/2
- 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
DISEASE CHARACTERISTICS:
- Diagnosis of muscle invasive transitional cell carcinoma of the bladder
- T2-4a, N0, M0 (stage II or III disease)
- No adenocarcinoma or squamous cell carcinoma
PATIENT CHARACTERISTICS:
- WHO performance status (PS) 0-2 or Karnofsky PS 70-100%
- Life expectancy ≥ 6 months
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 g/dL
- Creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for at least 2 months after completion of study treatment
- No other prior malignancy, except previously treated nonmalignant skin cancer or carcinoma in situ of the cervix
- No prior serious digestive complications (e.g., ulcerative colitis or complicated diverticulosis)
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy or chemotherapy (except for intravesical instillations)
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298
About this study
Official title: Phase 1-2 Study of the Association of Gemzar ® - Cisplatin-concurrent Radiotherapy in Patients With Non-metastatic Tumors of the Bladder
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when given together with cisplatin and radiation therapy and to see how well they work in treating patients with stage II or stage III bladder cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the incidence and nature of acute and late toxicity of gemcitabine hydrochloride, cisplatin, and concurrent radiotherapy in patients with stage II or III transitional cell carcinoma of the bladder. (Phase I)
- Determine the efficacy of this regimen, in terms of local tumor control (absence of local progression), in these patients. (Phase II)
Secondary
- Determine the maximum tolerated dose and the recommended phase II dose of gemcitabine hydrochloride when administered with cisplatin and radiotherapy in these patients. (Phase I)
- Assess the 5- and 10-year survival and the progression-free survival of patients treated with this regimen. (Phase II)
- Assess the quality of life of patients treated with this regimen. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of gemcitabine hydrochloride followed by a phase II, multicenter study.
Patients receive gemcitabine hydrochloride IV over 30 minutes twice weekly for 5 weeks and cisplatin IV continuously over 4 days on days 2-5 and 23-26 (weeks 1 and 4). Patients also undergo radiotherapy once daily 5 days a week for 5 weeks.
Three weeks after completion of treatment, patients undergo cystoscopy and transurethral resection (TUR). Patients with residual tumor or disease progression undergo radical TUR. After surgery, patients who achieve a complete response receive gemcitabine hydrochloride IV twice weekly for 2 weeks and cisplatin IV continuously over 4 days in week 1. Patients also undergo radiotherapy once daily 5 days a week for 2 weeks.
After completion of study treatment, patients are followed at 6-8 weeks and then 6 months thereafter.
- Conditions
- Bladder Cancer
- Being tested
- cisplatin, gemcitabine hydrochloride, biopsy, cystoscopy, therapeutic conventional surgery
- Keywords
- stage II bladder cancer, stage III bladder cancer, transitional cell carcinoma of the bladder
- 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.
cisplatinDrug
biopsyProcedure or surgery
cystoscopyProcedure or surgery
therapeutic conventional surgeryProcedure or surgery
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| gemcitabine, cisplatine, radiotherapy | Other | Not described Receives: Drug: cisplatin; Drug: gemcitabine hydrochloride; Procedure: biopsy; Procedure: cystoscopy; Procedure: therapeutic conventional surgery; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and nature of acute and late toxicity (Phase I)
Measured: From baseline to the end of treatment
Local tumor control (Phase II)
Measured: From baseline to the end of treatment
Secondary outcomes (4)
Maximum tolerated dose and recommended phase II dose of gemcitabine hydrochloride when administered with cisplatin and radiotherapy (Phase I)
Measured: From baseline to the end of treatment
5- and 10-year survival (Phase II)
Measured: until 5 and 10 year after the end of treatment
Progression-free survival (Phase II)
Measured: 6 to 8 weeks after to the end of treatment
Quality of life (Phase II)
Measured: From baselin to the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startJun 2005
- Primary completionAug 2009
- Study completionAug 2009
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.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe D'Etude des Tumeurs Uro-Genitales
- Responsible party
- Sponsor
- Investigators
- David Azria, MD, PhD, Study chair, Institut du Cancer de Montpellier - Val d'Aurelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556621
- Sponsor's protocol ID
- CDR0000574107
- Other IDs
- CLCC_GEMCIRAV, INCA-RECF0285, GETUG-CLCC-GEMCIRAV
- Acronym
- GEMCIRAV
- Status last verified
- Jul 2015
- First submitted
- 9 Nov 2007
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1-2 Study of the Association of Gemzar ® - Cisplatin-concurrent Radiotherapy in Patients With Non-metastatic Tumors of the Bladder
- ClinicalTrials.gov ID
- NCT00556621
- Acronym / sponsor ID
- GEMCIRAV / CDR0000574107
- Conditions
- Bladder Cancer
- Keywords
- stage II bladder cancer, stage III bladder cancer, transitional cell carcinoma of the bladder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Collaborators
- Groupe D'Etude des Tumeurs Uro-Genitales
- Study start
- Jun 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 12 Nov 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.
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when given together with cisplatin and radiation therapy and to see how well they work in treating patients with stage II or stage III bladder cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the incidence and nature of acute and late toxicity of gemcitabine hydrochloride, cisplatin, and concurrent radiotherapy in patients with stage II or III transitional cell carcinoma of the bladder. (Phase I)
- Determine the efficacy of this regimen, in terms of local tumor control (absence of local progression), in these patients. (Phase II)
Secondary
- Determine the maximum tolerated dose and the recommended phase II dose of gemcitabine hydrochloride when administered with cisplatin and radiotherapy in these patients. (Phase I)
- Assess the 5- and 10-year survival and the progression-free survival of patients treated with this regimen. (Phase II)
- Assess the quality of life of patients treated with this regimen. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of gemcitabine hydrochloride followed by a phase II, multicenter study.
Patients receive gemcitabine hydrochloride IV over 30 minutes twice weekly for 5 weeks and cisplatin IV continuously over 4 days on days 2-5 and 23-26 (weeks 1 and 4). Patients also undergo radiotherapy once daily 5 days a week for 5 weeks.
Three weeks after completion of treatment, patients undergo cystoscopy and transurethral resection (TUR). Patients with residual tumor or disease progression undergo radical TUR. After surgery, patients who achieve a complete response receive gemcitabine hydrochloride IV twice weekly for 2 weeks and cisplatin IV continuously over 4 days in week 1. Patients also undergo radiotherapy once daily 5 days a week for 2 weeks.
After completion of study treatment, patients are followed at 6-8 weeks and then 6 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gemcitabine, cisplatine, radiotherapy | Other | Drug: cisplatin, Drug: gemcitabine hydrochloride, Procedure: biopsy, Procedure: cystoscopy, Procedure: therapeutic conventional surgery, Radiation: radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| cisplatin | Drug | gemcitabine, cisplatine, radiotherapy |
| gemcitabine hydrochloride | Drug | gemcitabine, cisplatine, radiotherapy |
| biopsy | Procedure or surgery | gemcitabine, cisplatine, radiotherapy |
| cystoscopy | Procedure or surgery | gemcitabine, cisplatine, radiotherapy |
| therapeutic conventional surgery | Procedure or surgery | gemcitabine, cisplatine, radiotherapy |
| radiation therapy | Radiation | gemcitabine, cisplatine, radiotherapy |
Primary outcome
Incidence and nature of acute and late toxicity (Phase I)
Time frame: From baseline to the end of treatment
Local tumor control (Phase II)
Time frame: From baseline to the end of treatment
4 secondary outcomes
Maximum tolerated dose and recommended phase II dose of gemcitabine hydrochloride when administered with cisplatin and radiotherapy (Phase I)
Time frame: From baseline to the end of treatment
5- and 10-year survival (Phase II)
Time frame: until 5 and 10 year after the end of treatment
Progression-free survival (Phase II)
Time frame: 6 to 8 weeks after to the end of treatment
Quality of life (Phase II)
Time frame: From baselin to the end of treatment
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 30 Jul 2015.
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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.
David Azria, MD, PhD study chair
Institut du Cancer de Montpellier - Val d'Aurelle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing cisplatin, gemcitabine hydrochloride and biopsy in people with Bladder Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 30 Jul 2015. 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 France. 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 combined 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.
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 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?
Incidence and nature of acute and late toxicity (Phase I) (time frame: From baseline to the end of treatment). 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 30 Jul 2015.