Gemcitabine, Cisplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Bladder Cancer

Bladder Cancer Clinical Trial

— GEMCIRAV  

Official title:

Phase 1-2 Study of the Association of Gemzar ® - Cisplatin-concurrent Radiotherapy in Patients With Non-metastatic Tumors of the Bladder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00556621
• Other study ID #: CDR0000574107
• Secondary ID: CLCC_GEMCIRAVINC
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 9, 2007
• Last updated: July 29, 2015
• Start date: June 2005
• Est. completion date: August 2009

Study information

• Verified date: July 2015
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• cisplatin

• gemcitabine hydrochloride

Procedure:
• biopsy

• cystoscopy

• therapeutic conventional surgery

Radiation:
• radiation therapy

Locations

Country	Name	City	State
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle	Groupe D'Etude des Tumeurs Uro-Genitales

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and nature of acute and late toxicity (Phase I)		From baseline to the end of treatment	Yes
Primary	Local tumor control (Phase II)		From baseline to the end of treatment	No
Secondary	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	Yes
Secondary	5- and 10-year survival (Phase II)		until 5 and 10 year after the end of treatment	No
Secondary	Progression-free survival (Phase II)		6 to 8 weeks after to the end of treatment	No
Secondary	Quality of life (Phase II)		From baselin to the end of treatment	No