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

This study has been completed.
Sponsor:
Collaborators:
Centre Val d'Aurelle - Paul Lamarque
Groupe D'Etude des Tumeurs Uro-Genitales
Information provided by (Responsible Party):
National Cancer Institute, France
ClinicalTrials.gov Identifier:
NCT00556621
First received: November 9, 2007
Last updated: December 11, 2012
Last verified: December 2012
  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: cystoscopy
Procedure: therapeutic conventional surgery
Radiation: radiation therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, France:

Primary Outcome Measures:
  • Incidence and nature of acute and late toxicity (Phase I) [ Time Frame: From baseline to the end of treatment ] [ Designated as safety issue: Yes ]
  • Local tumor control (Phase II) [ Time Frame: From baseline to the end of treatment ] [ 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) [ Time Frame: From baseline to the end of treatment ] [ Designated as safety issue: Yes ]
  • 5- and 10-year survival (Phase II) [ Time Frame: until 5 and 10 year after the end of treatment ] [ Designated as safety issue: No ]
  • Progression-free survival (Phase II) [ Time Frame: 6 to 8 weeks after to the end of treatment ] [ Designated as safety issue: No ]
  • Quality of life (Phase II) [ Time Frame: From baselin to the end of treatment ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: June 2005
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
gemcitabine, cisplatine, radiotherapy Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: biopsy Procedure: cystoscopy Procedure: therapeutic conventional surgery Radiation: radiation therapy

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Sponsors and Collaborators
National Cancer Institute, France
Centre Val d'Aurelle - Paul Lamarque
Groupe D'Etude des Tumeurs Uro-Genitales
Investigators
Study Chair: David Azria, MD, PhD Centre Val d'Aurelle - Paul Lamarque
  More Information

Additional Information:
No publications provided

Responsible Party: National Cancer Institute, France
ClinicalTrials.gov Identifier: NCT00556621     History of Changes
Other Study ID Numbers: CDR0000574107, CLCC_GEMCIRAV, INCA-RECF0285, GETUG-CLCC-GEMCIRAV
Study First Received: November 9, 2007
Last Updated: December 11, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by National Cancer Institute, France:
stage II bladder cancer
stage III bladder cancer
transitional cell carcinoma of the bladder

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 22, 2014