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

Sponsored by:	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00556621

Purpose

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.

Condition	Intervention	Phase
Bladder Cancer	Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: biopsy Procedure: conventional surgery Procedure: cystoscopy Procedure: radiation therapy	Phase I Phase II

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

Drug Information available for: Cisplatin Gemcitabine hydrochloride Gemcitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized
Official Title:	Phase 1-2 Study of the Association of Gemzar ® - Cisplatin-Concurrent Radiotherapy in Patients With Non-Metastatic Tumors of the Bladder

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Incidence and nature of acute and late toxicity (Phase I) [ Designated as safety issue: Yes ]
Local tumor control (Phase II) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Maximum tolerated dose and recommended phase II dose of gemcitabine hydrochloride when administered with cisplatin and radiotherapy (Phase I) [ Designated as safety issue: Yes ]
5- and 10-year survival (Phase II) [ Designated as safety issue: No ]
Progression-free survival (Phase II) [ Designated as safety issue: No ]
Quality of life (Phase II) [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	May 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556621

Locations

France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Recruiting
Montpellier, France, 34298
Contact: David Azria, MD, PhD 33-4-6761-3132 azria@valdorel.fnclcc.fr

Sponsors and Collaborators

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Investigators

Study Chair:

David Azria, MD, PhD

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000574107, CLCC_GEMCIRAV, INCA-RECF0285, GETUG-CLCC-GEMCIRAV
Study First Received:	November 9, 2007
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00556621
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage II bladder cancer
stage III bladder cancer
transitional cell carcinoma of the bladder

Study placed in the following topic categories:

Cystocele
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Urogenital Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Transitional cell carcinoma

Carcinoma
Urologic Diseases
Cisplatin
Gemcitabine
Urinary tract neoplasm
Bladder neoplasm

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 15, 2009