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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Spanish Oncology Genito-Urinary Group
ClinicalTrials.gov Identifier:
NCT01529411
First received: January 20, 2012
Last updated: December 17, 2014
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

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.


Enrollment: 86
Study Start Date: February 2012
Study Completion Date: December 2014
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
Elda, Alicante, Spain, 03600
ICO-Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
ICO-Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Hospital Fundació Althaia
Manresa, Barcelona, Spain, 08243
Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, Spain, 08208
Complejo Hosp. Univ. de Santiago de Compostela
Santiago de Compostela, Galicia, Spain, 15706
Hospital Universitario Fundación Alcorcón
Alcorcon, Madrid, Spain, 28922
H. del Mar (Fundació Institut Mar d´Investigacions Mèdiques - FIMIM)
Barcelona, Spain, 08003
H. Universitari Vall d'Hebrón
Barcelona, Spain, 08035
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain, 08036
H. General Universitario de Ciudad Real
Ciudad Real, Spain, 13005
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitari Son Espases
Palma de Mallorca, Spain, 07010
Clínica Universitaria de Navarra (CUN)
Pamplona, Spain, 31002
Complejo Hospitalario de Navarra
Pamplona, Spain, 31008
H. Universitario Virgen de la Macarena
Sevilla, Spain, 41009
H. Universitario Virgen del Rocío
Sevilla, Spain, 41013
IVO
Valencia, Spain, 46009
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: December 17, 2014
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, Transitional Cell
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 04, 2015