Gemcitabine, Cisplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Bladder Cancer
- Conditions
- Bladder Cancer
- Interventions
- Procedure: biopsyProcedure: cystoscopyProcedure: therapeutic conventional surgeryRadiation: radiation therapy
- Registration Number
- NCT00556621
- Lead Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description gemcitabine, cisplatine, radiotherapy gemcitabine hydrochloride - gemcitabine, cisplatine, radiotherapy radiation therapy - gemcitabine, cisplatine, radiotherapy biopsy - gemcitabine, cisplatine, radiotherapy cystoscopy - gemcitabine, cisplatine, radiotherapy therapeutic conventional surgery - gemcitabine, cisplatine, radiotherapy cisplatin -
- Primary Outcome Measures
Name Time Method Incidence and nature of acute and late toxicity (Phase I) From baseline to the end of treatment Local tumor control (Phase II) From baseline to the end of treatment
- Secondary Outcome Measures
Name Time Method Maximum tolerated dose and recommended phase II dose of gemcitabine hydrochloride when administered with cisplatin and radiotherapy (Phase I) From baseline to the end of treatment Quality of life (Phase II) From baselin to the end of treatment Progression-free survival (Phase II) 6 to 8 weeks after to the end of treatment 5- and 10-year survival (Phase II) until 5 and 10 year after the end of treatment
Trial Locations
- Locations (1)
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France