Gemcitabine, Cisplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Bladder Cancer (GEMCIRAV)
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.
|Bladder Cancer||Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: biopsy Procedure: cystoscopy Procedure: therapeutic conventional surgery Radiation: radiation therapy||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1-2 Study of the Association of Gemzar ® - Cisplatin-concurrent Radiotherapy in Patients With Non-metastatic Tumors of the Bladder|
- 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 ]
- 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 ]
|Study Start Date:||June 2005|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
|gemcitabine, cisplatine, radiotherapy||Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: biopsy Procedure: cystoscopy Procedure: therapeutic conventional surgery Radiation: radiation therapy|
- 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)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556621
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Study Chair:||David Azria, MD, PhD||Institut du Cancer de Montpellier - Val d'Aurelle|