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

NCT00556621 | Completed Phase 1

• 4 other identifiers: CDR0000574107CLCC_GEMCIRAVINCA-RECF0285GETUG-CLCC-GEMCIRAV
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Incidence and nature of acute and late toxicity (Phase I)

  From baseline to the end of treatment

• Local tumor control (Phase II)

  From baseline to the end of treatment

Secondary Outcomes (4)

• 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

• 5- and 10-year survival (Phase II)

  until 5 and 10 year after the end of treatment

• Progression-free survival (Phase II)

  6 to 8 weeks after to the end of treatment

• Quality of life (Phase II)

  From baselin to the end of treatment

Study Arms (1)

gemcitabine, cisplatine, radiotherapy

OTHER

Drug: cisplatin; Drug: gemcitabine hydrochloride; Procedure: biopsy; Procedure: cystoscopy; Procedure: therapeutic conventional surgery; Radiation: radiation therapy

Interventions

cisplatin DRUG

gemcitabine, cisplatine, radiotherapy

gemcitabine hydrochloride DRUG

gemcitabine, cisplatine, radiotherapy

biopsy PROCEDURE

gemcitabine, cisplatine, radiotherapy

cystoscopy PROCEDURE

gemcitabine, cisplatine, radiotherapy

therapeutic conventional surgery PROCEDURE

gemcitabine, cisplatine, radiotherapy

radiation therapy RADIATION

gemcitabine, cisplatine, radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead
• Groupe D'Etude des Tumeurs Uro-Genitales: collaborator

Study Sites (1)

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

Montpellier, 34298, France

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Cisplatin; Gemcitabine; Biopsy; Cystoscopy; Radiotherapy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Endoscopy; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Urologic Surgical Procedures; Urogenital Surgical Procedures; Therapeutics

Study Officials

• David Azria, MD, PhD

  Institut du Cancer de Montpellier - Val d'Aurelle

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: June 1, 2005
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: July 30, 2015

Record last verified: 2015-07

Locations

FR (1)