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Cisplatin and Gemcitabine Compared With Observation in Treating Patients Who Have Undergone Surgery for Bladder Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00054626
First received: February 5, 2003
Last updated: December 17, 2013
Last verified: November 2008
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known if combination chemotherapy is effective in preventing relapse in patients who have undergone radical cystectomy for bladder cancer.

PURPOSE: Phase III trial to compare the effectiveness of cisplatin combined with gemcitabine with that of observation in treating patients with bladder cancer who have undergone surgery to remove the bladder.


Condition Intervention Phase
Bladder Cancer
Drug: cisplatin
Drug: gemcitabine hydrochloride
Procedure: adjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Study Of Adjuvant Cisplatin-Gemcitabine Vs. Observation After Radical Cystectomy In High-Risk Bladder Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall survival at 5 years [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-free survival at 5 years [ Designated as safety issue: No ]
  • Local disease-free survival at 5 years [ Designated as safety issue: No ]
  • Distant disease-free survival at 5 years [ Designated as safety issue: No ]
  • Toxicity by WHO system grading after each course [ Designated as safety issue: Yes ]
  • Quality of life after each course and every 6 months during follow-up [ Designated as safety issue: No ]
  • Dose intensity at the end of the treatment [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: September 2001
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Compare the overall, cause-specific, and disease-free survival of patients with high-risk muscle-invasive transitional cell carcinoma of the bladder treated with adjuvant cisplatin and gemcitabine vs observation after radical cystectomy.
  • Compare the dose intensity and toxicity of two different schedules of cisplatin and gemcitabine in these patients.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and disease status (T2 [G3 only] or T3-4 [any G], N0-2 vs any T, N1-2, M0). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients are further randomized to 1 of 2 treatment regimens.

    • Regimen A: Patients receive cisplatin IV on day 2 and gemcitabine IV on days 1, 8, and 15.
    • Regimen B: Patients receive cisplatin IV on day 15 and gemcitabine as in regimen A.

Treatment in both regimens repeats every 28 days for 4 courses.

  • Arm II: Patients undergo observation followed by cisplatin and gemcitabine as in arm I at relapse.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 700 patients (350 per treatment arm) will be accrued for this study within 3 years.

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed transitional cell carcinoma of the bladder

    • T2 (G3 only) or T3-4 (any G), N0-2 or any T, N1-2, M0
    • No secondary localization
  • Radical cystectomy (without residual disease) performed within 10 weeks prior to study entry to include:

    • Men: Cystectomy with removal of prostate and seminal vesicles including 1.5 cm of urethra plus pelvic lymphadenectomy (at least 15 negative lymph nodes are recommended to define as N0)
    • Women: Cystectomy with complete removal of the bladder, uterus, ovaries, and anterior walls of the vagina plus pelvic lymphadenectomy

PATIENT CHARACTERISTICS:

Age

  • 18 to 74

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC at least 3,500/mm^3
  • Absolute neutrophil count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic

  • Bilirubin less than upper normal limit (ULN)
  • Gamma-GT less than ULN
  • SGOT and SGPT no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN

Renal

  • Creatinine no greater than1.25 times ULN
  • Creatinine clearance at least 60 mL/min

Cardiovascular

  • No congestive heart failure
  • No angina pectoris
  • No cardiac arrhythmia
  • No uncontrolled arterial hypertension
  • No history of acute myocardial infarction within the past year

Other

  • No other serious concurrent illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior systemic chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • Palliative radiotherapy allowed at relapse for symptomatic bone metastases

Surgery

  • See Disease Characteristics
  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: NCT00054626

  Hide Study Locations
Locations
Italy
Ospedale Civile Via Caronia
Acireale - CT, Italy, 95024
Ospedale San Lazzaro
Alba, Italy, 12051
Ospedale S. Giuseppe
Albano, Italy, 00041
Ospedale Civile Alessandria
Alessandria, Italy, I-15100
Ospedale SS. Biagio e Arrigo
Alessandria, Italy, 15100
Presidio Ospedale
Anagni, Italy, 03012
Ospedale Torrette University Ancona
Ancona, Italy, 60020
Ospedale Generale Umberto 1
Ancona, Italy, 60100
Istituto Nazionale Riposo e Cura Anziani Istituto
Ancona - AN, Italy, 60100
Ospedale S. Donato
Arezzo, Italy, 52100
Ospedale Civile di Asti
Asti, Italy, 14100
S.G. Moscati Hospital
Avellino, Italy, 83100
Ospedale Civile Avezzano
Avezzano, Italy, 67051
Centro di Riferimento Oncologico - Aviano
Aviano, Italy, 33081
Universita Degli Studi di Bari
Bari, Italy, 70124
Istituto Di Ricovero E Cura A Carattere Scientifico
Bari, Italy, 70126
Ospedale di Venere - Carbonara
Bari-Carbonara, Italy, 70100
Ospedale S. Martino
Belluno, Italy, 32100
Ospedali Riuniti di Bergamo
Bergamo, Italy, 24100
Ospedale degli Infermi - ASL 12
Biella, Italy, 13900
Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi
Bologna, Italy, 40138
Azienda Sanitaria di Bolzano
Bolzano, Italy, 39100
Ospedale S. Trinita
Borgomanero, Italy, 28021
Spedali Civili di Brescia
Brescia, Italy, 25124
Ospedale di Busto Arsizio
Busto Arsizio, Italy, 21052
Ospedale SS Trinita
Cagliari, Italy, 09100
Ospedale Caltanissetta
Caltanissetta, Italy, 93100
Ospedale Civile Camposanpiero
Camposanpiero, Italy, 35012
Istituto per la Ricerca e Cura del Cancro
Candiolo, Italy, 10060
Civic Hospital of Carrara
Carrara, Italy, I-54033
Ospedale S. Spirito
Casale Monferrato, Italy, 15033
Ospedale S. Leonardo
Castellammare di Stabia - NA, Italy, 80053
Ospedale Cannnizzaro
Catania, Italy, 95100
Ospedale S. Luigi
Catania, Italy, 95100
Ospedale Regionale A. Pugliese
Catanzaro, Italy, 88100
Ospedale SS Annunziata
Chieti, Italy, 66100
Universita G.D'Annunzio Di Chieti
Chieti, Italy, 66100
Ospedale Di Cirie
Cirie, Italy, 10073
Ospedale Sant Anna
Como, Italy, 22100
Ospedale Maggiore Crema
Crema, Italy, 26013
Ospedale Civile S. Croce
Fano, Italy, 61032
Ospedale Fidenza
Fidenza, Italy, 43036
Ospendale S.M. Annunziata-A.S.DI Florence
Florence, Italy, I-50011
Morgagni-Pierantoni Ospedale
Forli, Italy, 47100
Ospedale S. Sebastiano
Frascati - RM, Italy, 00044
Ospedale Umberto I
Frosinone, Italy, 03100
Ospedale S. Antonio Abate
Gallarate Varese, Italy, 21013
Ospedale Di Gela
Gela - CL, Italy, 930123
Istituto Nazionale per la Ricerca sul Cancro
Genoa, Italy, 16132
Ospedale San Martino
Genoa, Italy, 16132
Presidio Ospedaliero-Gorizia
Gorizia, Italy, 34170
Ospedale Misericordia USL 9
Grosseto, Italy, 58100
INI Grottaferrata
Grottaferrata, Italy, 00046
Ospedale Nuovo
Imola, Italy, 40026
Ospedali Vecchi
Imola, Italy, 40026
Ospedale Civile di Ivrea
Ivrea, Italy, 10015
Ospendale S. Andrea EST
La Spezia, Italy, 19100
Ospedale Civile Lanciano
Lanciano, Italy, 66034
Ospedale Santa Maria Goretti
Latina, Italy, 04100
Ospedale Alessandro Manzoni
Lecco, Italy, 23900
Ospedale Civile di Legnano
Legnano, Italy, 20025
Presidio Ospedaliero di Livorno
Livorno, Italy, 57100
Carlo Poma Hospital
Mantova, Italy, 46100
Ospedale Papardo
Messina, Italy, 98100
Policlinico Messina
Messina, Italy, 98123
University of Milan
Milan, Italy, 20122
European Institute of Oncology
Milan, Italy, 20141
Istituto Scientifico H. San Raffaele
Milan, Italy, 20132
Ospedale Fatebene Fratelli
Milan, Italy, 20152
Ospedale San Carlo Borromeo
Milan, Italy, 20153
Ospedale San Giuseppe
Milan, Italy, 20123
Ospedale Luigi Sacco
Milan, Italy, 20157
Azienda Ospedaliera - Universitaria di Modena
Modena, Italy, 41100
Sant Agostino - Estenes Institutes
Modena, Italy, 41100
Policlinico Monserrato
Monserrato - CA, Italy, 09042
Ospedale San Gerardo
Monza, Italy, 20052
Clinica Urologica II
Monza, Italy, 20052
Azienda Ospedaliera "A. Cardarelli"
Naples, Italy, 80127
Federico II University Medical School
Naples, Italy, 80131
Istituto Tumori/Fondazione Pascale
Naples, Italy, 80131
Ospedale Civile Negrar
Negrar, Italy, 37024
Azienda Ospedaliera Maggiore Della Carita
Novara, Italy, 28100
Azienda Ospedale S. Luigi at University of Torino
Orbassano, Italy, 10043
Casa di Cura Noto Pasqualino
Palermo, Italy, 90100
Ospedale La Maddalena - Palermo
Palermo, Italy
Ospedale Oncology M. Ascoli
Palermo, Italy, 90100
Azienda Ospedaliera Di Parma
Parma, Italy, 43100
Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia, Italy, 27100
Universita Degli Studi
Pavia, Italy, 27100
Azienda Ospedale - d "S. Salvatore"
Pesaro, Italy, 61100
Ospedale Spiritito Santo
Pescara, Italy, 65100
Ospedale Santa Corona
Pietra Ligure -SV, Italy, 17029
Ospedale Santa Chiara Pisa
Pisa, Italy, I-56126
Ospedale Pistoia
Pistoia, Italy, 51100
Azienda Ospedaliera "Santa Maria Degli Angeli"
Pordenone, Italy, 33170
Azienda U.S.L. Cesena
Potenza, Italy, 85100
Ospedale Carlo Forlanini
Potenza, Italy, 85100
Ospedale Di Rivoli
Rivoli, Italy, 10098
Ospedale San Pietro Fatebenefratelli
Rome, Italy, 00189
Azienda Ospedaliera Sant'Andrea
Rome, Italy, 00100
Azienda Policlinico Umberto Primo
Rome, Italy, 00161
Fatebenefratelli, Isola Tiberina Hospital
Rome, Italy, 00186
Istituto Regina Elena
Rome, Italy, 00161
Ospedale C.T.O. Roma
Rome, Italy, 00100
Azienda Ospedaliera S. Camillo-Forlanini
Rome, Italy, 00151
Ospedale Sant' Eugenio
Rome, Italy, 00144
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, Italy, 00168
Ospedale Civile di Rovigo
Rovigo, Italy, 45100
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Ospedale Saluzzo
Saluzzo - CN, Italy, 12037
Ospedale San Daniele del Friuli
San Daniele del Friuli, Italy, 33038
Ospedale Casa Sollievo della Sofferenza
San Giovanni - Rotondo, Italy, 71013
ASL NO. 1 Imperiese
San Remo, Italy, 18038
Ospedale Civile G Borea
San Remo, Italy, 18038
Ospedale Civile Di San Vito Al Tagliamento
San Vito Al Talgliamento, Italy
Az. Ospedale Villa Scassi
Sandpierdarena, Italy, 16100
Istituto Clinica Medica
Sassari, Italy, 07100
Ospedale Civile ASL 1
Sassari, Italy, 07100
Ospedale SS Trinita
Sassari, Italy, 07100
Policlinico Sassari
Sassari, Italy, 07100
Ospedali Savigliano
Savigliano - CN, Italy, 12038
Ospedale S. Paolo Valloria
Savona, Italy, 17100
Ospedale Civile Sestri Levante
Sestri Levante - GE, Italy, 16039
Universita di Siena
Siena, Italy, 53100
Ospedale Umberto 1
Siracusa, Italy, 95100
Osepdale Civile
Sondrio, Italy, 23100
Ospedale SS Trinita
Sora, Italy, 03039
SS Annunziata
Sulmona, Italy, 67039
Ospedale S. Vincenzo
Taormina, Italy, 98039
Ospedale Civile Teramo
Teramo, Italy, 64100
Ospedale Generale Prov. Boldrini
Thiene, Italy, 36016
Ospedale Civile
Tolmezzo Gemona F., Italy, 33013
Ospedale Civile Trapani
Trapani, Italy, 91100
Ospedale Di Trento
Trento, Italy, 38100
Primario U.O. di Oncologia Medica
Trento, Italy, 38100
Ospedale Cattinara
Trieste, Italy
Ospedale Giovanni Bosco
Turin, Italy
Ospedale Amedeo Savoia
Turin, Italy, 10100
Ospedale Cottolengo
Turin, Italy
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
Turin, Italy, 10126
Ospedale Gradenigo
Turin, Italy, 10153
Ospedale Martini
Turin, Italy, 10100
Ospedale S. Giovanni Vecchio
Turin, Italy
Azienda Ospedaliera Santa Maria della Misericordia
Udine, Italy, 33100
Ospedale Civile ULSS 12
Venezia, Italy, 30100
Ospedale Civile Verbania
Verbania, Italy, 28900
Ospedal San Andrea
Vercelli, Italy, 13100
Policlinico Borgo Roma
Verona, Italy, 37134
Policlinico G. B. Rossi - Borgo Roma
Verona, Italy, 37134
Ospedale San Bortolo
Vicenza, Italy, 36100
Presidio Ospedaliero Belcolle
Viterbo, Italy, I-01100
Sponsors and Collaborators
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Investigators
Study Chair: Camillo F. Pollera, MD Presidio Ospedaliero Belcolle
  More Information

Publications:
Pollera CF, Merendino N, Cianciulli AM, et al.: Preliminary cytogenetic and pharmacogenomic analysis of muscle-invasive transitional-cell carcinoma (TCC) of the bladder in patients (pts) enrolled in the Italian National Research Council (CNR) phase III randomized trial comparing adjuvant cisplatin-gemcitabine (PG) vs observation (OBS) after radical cystectomy. [Abstract] J Clin Oncol 23 (Suppl 16): A-4589, 400s, 2005.

ClinicalTrials.gov Identifier: NCT00054626     History of Changes
Other Study ID Numbers: CDR0000258426, ITNRC-CU02.00447ST/97, NCI-V02-1715
Study First Received: February 5, 2003
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II bladder cancer
stage III bladder cancer
stage IV bladder cancer
transitional cell carcinoma of the bladder

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

ClinicalTrials.gov processed this record on November 27, 2014