A Phase 1/2 interventional study of cisplatin and gemcitabine hydrochloride in Bladder Cancer, sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-30.
Sponsored by Institut du Cancer de Montpellier - Val d'Aurelle · Phase 1/2, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's enrollment of 14 is below the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Institut du Cancer de Montpellier - Val d'Aurelle is the lead sponsor of 138 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of muscle invasive transitional cell carcinoma of the bladder
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Drug: cisplatin · Drug: gemcitabine hydrochloride · Procedure: biopsy · Procedure: cystoscopy · Procedure: therapeutic conventional surgery · Radiation: radiation therapy
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
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Institut du Cancer de Montpellier - Val d'Aurelle