Clinical Trial With Vinflunine as Maintenance Therapy in Metastatic Urothelial Cancer (MAJA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Spanish Oncology Genito-Urinary Group.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Spanish Oncology Genito-Urinary Group
ClinicalTrials.gov Identifier:
NCT01529411
First received: January 20, 2012
Last updated: February 7, 2012
Last verified: February 2012
  Purpose

This is a clinical trial to evaluate the efficacy and safety of the drug vinflunine administered after the standard treatment of the combination gemcitabine+cisplatin, when it has reached stabilization or response of the disease, as the first treatment inmeditely after the diagnosis of advanced or metastatic urothelial cancer.


Condition Intervention Phase
Carcinoma, Transitional Cell
Drug: Vinflunine
Other: Undefined (standard care)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of Vinflunine as Maintenance Monotherapy in Patients With Advanced or Metastatic Urothelial Cancer That Obtains Clinical Benefit of the First Line With Cisplatin-gemcitabine Combination

Resource links provided by NLM:


Further study details as provided by Spanish Oncology Genito-Urinary Group:

Primary Outcome Measures:
  • Progression Free Survival. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To evaluate the Progression Free Survival (PFS) with vinflunine in maintenance monotherapy in patients with advanced or metastatic CCTU that has reached stabilization or objective response after completing 6 cycles with the combination cisplatin-gemcitabine in 1st line.


Estimated Enrollment: 86
Study Start Date: February 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vinflunine

Vinflunine 320 mg/m2 IV infusion in 20 minutes every 21 days (280mg/m2 if PS=1, age ≥ 75 years, previous pelvic radiotherapy or creatinine clearance < 60ml/min)

+ best suportive care, with regards clinical practice.

Drug: Vinflunine
Vinflunine 320 mg/m2 IV infusion in 20 minutes every 21 days (280mg/m2 if PS=1, age ≥ 75 years, previous pelvic radiotherapy or creatinine clearance < 60ml/min).
Other Name: Javlor
Best suportive care
Best suportive care
Other: Undefined (standard care)
All the current interventions used by each institution for the study disease.
Other Name: undefined

Detailed Description:

Vinflunine is a drug recently approved in Europe for the treatment of advanced or metastatic urothelial cancer after platinum-failure. It has proved to improve the survival results compared with the best suportive care. In adition, the tolerability was favourable, specially for not leading appearance of neuropathy nor other cumulative toxic effects.

In this study, it is proposed to test the feasibility, in terms of tolerability and efficacy of monotherapy with vinflunine in patients who, after completing the first-line cisplatin-based treatment for Transitional Cell Carcinoma of the Urothelial Tract (CCTU), have reached a stabilization or objective response. In order to have an adequate control group in the proposed design will be a phase II trial in which one group will receive standard management (follow-up until progression disease).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 & < 80
  • Written informed consent given by the patient
  • Diagnosis of urothelium cells transition cancer subsidiary locally advanced or metastatic resection
  • One measurable target lesion minimum
  • ECOG 0 or 1
  • Stabilization or objective response after first-line treatment 6 cycles of cisplatin+gemcitabine
  • Last administration of cisplatin and gemcitabine < 6 weeks
  • Maximum grade I toxicity
  • Adequate functions of bone marrow, kidney and liver
  • Absence psychological, family, sociological or geographical disorder or other condition
  • Women of childbearing potential must be using a medically accepted method of contraception (i.e. oral contraceptives, intrauterine devices) to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of pregnancy is minimised. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment.
  • Fertile men must be using an effective method of birth control if their partners are women of childbearing potential up to 3 months after last administration of study medication.

Exclusion Criteria:

  • ECOG > 2
  • Patients with age > 80
  • Patients with small cell carcinoma histology, lymphomas or sarcomas of the bladder.
  • The patients that have received 7 or more cycles of a combination of cisplatin and gemcitabine in first line metastatic disease.
  • Pregnant or lactating women or women with positive pregnancy test at screening, fertile sexual active women that did not use or do not wish or are unable to use an accepted method to prevent pregnancy during the 2 months prior to study treatment, during the study period and up to 3 months after the last dose of study treatment. Sexual active men who do not wish to use a method of birth during the study and up to 6 months after the last dose of study treatment if their partners are women of childbearing age.
  • Known brain metastases or meningeal involvement. CT Scan not required to rule this unless there is clinical suspicion of disease of the central nervous system.
  • Peripheral neuropathy grade 2 according to NCI-CTC version 4.0 [Common Toxicity Criteria of the National Cancer Institute].
  • Prior radiation to > 30% of the bone marrow, radiation completed at least 30 days or current persistence of any adverse event.
  • Other serious diseases or medical conditions like: systemic infection that required a systemic anti-infective treatment(grades 3 or 4 of the Common Toxicity Criteria NCI, version 4.03) and uncontrolled medical disorder, for example: patients with unstable angina or myocardial infarction within 6 months before registration or uncontrolled diabetes.
  • Progressive Disease during 1st line treatment of advanced or metastatic disease with chemotherapy systemic cisplatin and gemcitabine.
  • Patients who have received more than one line of treatment for metastatic disease.
  • Patients who received cisplatin in monotherapy or in combination as neoadjuvant treatment, adjuvant after initial surgery of urothelial cancer.
  • Patients treated with another investigational drug or treatment antineoplastic agent cisplatin or gemcitabine than within 30 days before randomization.
  • Other cancers except basal skin cancer treated in an appropriate, cervical cancer in situ or other tumor a disease-free interval of 5 years.
  • Inadequate renal function defined by a calculated clearance serum creatinine < 40 ml/min (Cockcroft-Gault).
  • Known hypersensitivity to drug study or similar chemical structure drugs.
  • Patients who require treatment with ketoconazole, itraconazole, ritonavir, amprenavir, indinavir, rifampin or phenytoin (any potent inhibitor or inducer of CYP3A4).
  • Any concurrent chronic immunotherapy or prior organic allograft.
  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: NCT01529411

Locations
Spain
Hospital General de Elda Virgen de la Salud Not yet recruiting
Elda, Alicante, Spain, 03600
Contact: Sonia Maciá, MD    +34 966 989 109    smacia@yahoo.com   
Principal Investigator: Sonia Macia, MD         
ICO-Hospital Universitari Germans Trias i Pujol Not yet recruiting
Badalona, Barcelona, Spain, 08916
Contact: Albert Font, MD    +34 93 497 8729    afont@iconcologia.net   
Principal Investigator: Albert Font, MD         
ICO-Hospital Duran i Reynals Not yet recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Contact: Xavier García, MD    +34 93 260 78 22    garciadelmuro@iconcologia.net   
Principal Investigator: Xavier García del Muro, MD         
Hospital Fundació Althaia Not yet recruiting
Manresa, Barcelona, Spain, 08243
Contact: Montserrat Domenech, MD    +34 93 874 21 12 ext 3221    mdomenech@althaia.cat   
Principal Investigator: Montserrat Domènech, MD         
Corporació Sanitaria Parc Taulí Not yet recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Enrique Gallardo, MD    +34 93 724 2759    egallardo@tauli.cat   
Principal Investigator: Enrique Gallardo, MD         
Complejo Hosp. Univ. de Santiago de Compostela Not yet recruiting
Santiago de Compostela, Galicia, Spain, 15706
Contact: Luis León, MD    +34 981 95 05 11    luis.leon.mateos@sergas.es   
Principal Investigator: Luís León, MD         
Hospital Universitario Fundación Alcorcón Not yet recruiting
Alcorcon, Madrid, Spain, 28922
Contact: Jesús García-Donas, MD    +34 91 621 94 90    jgarciadonas@fhalcorcon.es   
Principal Investigator: Jesús García-Donas, MD         
Hospital Clínic i Provincial de Barcelona Not yet recruiting
Barcelona, Spain, 08036
Contact: Begoña Mellado, MD    +34 932275400 ext 2811    bmellado@clinic.ub.es   
Principal Investigator: Begoña Mellado, MD         
H. Universitari Vall d'Hebrón Not yet recruiting
Barcelona, Spain, 08035
Contact: Joan Carles, MD    +34 93 489 43 74    jcarles@vhio.net   
Principal Investigator: Joan Carles, MD         
H. del Mar (Fundació Institut Mar d´Investigacions Mèdiques - FIMIM) Not yet recruiting
Barcelona, Spain, 08003
Contact: Joaquim Bellmunt, MD    +34 93 248 3609    JBellmunt@parcdesalutmar.cat   
Principal Investigator: Joaquim Bellmunt, MD         
H. General Universitario de Ciudad Real Not yet recruiting
Ciudad Real, Spain, 13005
Contact: José Carlos Villa, MD    +34 926 278 000 ext 77137    jvillaguzman1@yahoo.es   
Principal Investigator: José Carlos Villa, MD         
Hospital Clínico San Carlos Not yet recruiting
Madrid, Spain, 28040
Contact: Javier Puente, MD    +34 91 330 3000 ext 7545    jpuente.hcsc@salud.madrid.org   
Principal Investigator: Javier Puente, MD         
Hospital Universitario 12 de Octubre Not yet recruiting
Madrid, Spain, 28041
Contact: Daniel Castellano, MD    +34 91390 80 03    cdanicas@hotmail.com   
Principal Investigator: Daniel Castellano, MD         
Hospital General Universitario Gregorio Marañon Not yet recruiting
Madrid, Spain, 28007
Contact: José Angel Arranz, MD    +34 91 426 93 92    jarranza.oncomed@gmail.com   
Principal Investigator: Jose Angel Arranz, MD         
Hospital Universitari Son Espases Not yet recruiting
Palma de Mallorca, Spain, 07010
Contact: María Aranzazu González, MD    +34 871 20 59 70    aranzazu.gonzalezdelalba@ssib.es   
Principal Investigator: Mª Aránzazu González, MD         
Complejo Hospitalario de Navarra Not yet recruiting
Pamplona, Spain, 31008
Contact: Nuria Lainez, MD    +34 848 422 576    nuria.lainez.milagro@cfnavarra.es   
Principal Investigator: Nuria Lainez, MD         
Clínica Universitaria de Navarra (CUN) Not yet recruiting
Pamplona, Spain, 31002
Contact: José Luís Pérez, MD    +34 948 25 54 00 ext 5866    jlgracia@unav.es   
Principal Investigator: Jose Luis Perez, MD         
H. Universitario Virgen del Rocío Not yet recruiting
Sevilla, Spain, 41013
Contact: Begoña Pérez, MD    +34 955013068    bperezv@gmail.com   
Principal Investigator: Begoña Perez, MD         
H. Universitario Virgen de la Macarena Not yet recruiting
Sevilla, Spain, 41009
Contact: Juan Antonio Virizuela, MD    +34 955926578    oncojavirizuela@gmail.com   
Principal Investigator: Juan Antonio Virizuela, MD         
IVO Not yet recruiting
Valencia, Spain, 46009
Contact: Miguel Angel Climent, MD    +34 96 111 4013    macliment@fivo.org   
Principal Investigator: Miguel Angel Climent, MD         
Sponsors and Collaborators
Spanish Oncology Genito-Urinary Group
Investigators
Principal Investigator: Jesús García-Donas, MD Hospital Universitario Fundación Alcorcón.
Principal Investigator: Albert Font, MD ICO-Hospital Universitari Germans Trias i Pujol
Principal Investigator: Joaquim Bellmunt, MD H. del Mar - FIMIM (Fundació Institut Mar d´Investigacions Mèdiques)
  More Information

Additional Information:
No publications provided

Responsible Party: Spanish Oncology Genito-Urinary Group
ClinicalTrials.gov Identifier: NCT01529411     History of Changes
Other Study ID Numbers: SOGUG2011/02
Study First Received: January 20, 2012
Last Updated: February 7, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Spanish Oncology Genito-Urinary Group:
urothelium
transitional
carcinoma
cancer
metastatic
tract

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on September 22, 2014