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Carcinoma, Transitional CellPhase 2MAJANCT01529411

Clinical Trial With Vinflunine as Maintenance Therapy in Metastatic Urothelial Cancer

A Phase 2 study testing Vinflunine in people with Carcinoma, Transitional Cell, run by Spanish Oncology Genito-Urinary Group at 20 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Carcinoma, Transitional Cell
What is being tested?
Vinflunine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
20 sitesSpain
Study dates
Feb 2012to Dec 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Spain20 sites

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid, 28922

  • ICO-Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • H. del Mar (Fundació Institut Mar d´Investigacions Mèdiques - FIMIM)

    Barcelona, 08003

  • H. Universitari Vall d'Hebrón

    Barcelona, 08035

  • Hospital Clínic i Provincial de Barcelona

    Barcelona, 08036

  • H. General Universitario de Ciudad Real

    Ciudad Real, 13005

  • Hospital General de Elda Virgen de la Salud

    Elda, Alicante, 03600

  • ICO-Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Fundació Althaia

    Manresa, Barcelona, 08243

  • Hospital Universitari Son Espases

    Palma de Mallorca, 07010

  • Clínica Universitaria de Navarra (CUN)

    Pamplona, 31002

  • Complejo Hospitalario de Navarra

    Pamplona, 31008

  • Corporació Sanitaria Parc Taulí

    Sabadell, Barcelona, 08208

  • Complejo Hosp. Univ. de Santiago de Compostela

    Santiago de Compostela, Galicia, 15706

  • H. Universitario Virgen de la Macarena

    Seville, 41009

  • H. Universitario Virgen del Rocío

    Seville, 41013

  • IVO

    Valencia, 46009

Other trials in Spain

About this study

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

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.

Read the 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).

Being tested
Vinflunine, Undefined (standard care)
Keywords
urothelium, transitional, carcinoma, cancer, metastatic, tract
Medical subject headings
Carcinoma, Transitional Cell, Carcinoma, Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VinflunineDrug

    Also called Javlor

    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).

  • Undefined (standard care)Other

    Also called undefined

    All the current interventions used by each institution for the study disease.

Study groups in NCT01529411
Study groupRoleWhat they receive
VinflunineExperimentalVinflunine 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.
Receives: Drug: Vinflunine
Best suportive careOtherBest suportive care
Receives: Other: Undefined (standard care)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival.

    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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionFeb 2013
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01529411
Sponsor's protocol ID
SOGUG2011/02
Acronym
MAJA
Status last verified
Feb 2012
First submitted
20 Jan 2012
Last updated
4 Apr 2019
Results posted
No
Data monitoring committee
No

Publications

  • Garcia-Donas J, Font A, Perez-Valderrama B, Virizuela JA, Climent MA, Hernando-Polo S, Arranz JA, Del Mar Llorente M, Lainez N, Villa-Guzman JC, Mellado B, Gonzalez Del Alba A, Castellano D, Gallardo E, Anido U, Garcia Del Muro X, Domenech M, Puente J, Morales-Barrera R, Perez-Gracia JL, Bellmunt J. Maintenance therapy with vinflunine plus best supportive care versus best supportive care alone in patients with advanced urothelial carcinoma with a response after first-line chemotherapy (MAJA; SOGUG 2011/02): a multicentre, randomised, controlled, open-label, phase 2 trial. Lancet Oncol. 2017 May;18(5):672-681a. doi: 10.1016/S1470-2045(17)30242-5. Epub 2017 Apr 4.

    PubMed 28389316

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vinflunine in people with Carcinoma, Transitional Cell, run by Spanish Oncology Genito-Urinary Group at 20 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01529411, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.

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