Clinical Trial With Vinflunine as Maintenance Therapy in Metastatic Urothelial Cancer

NCT01529411 | Completed Phase 2

• 1 other identifier: SOGUG2011/02
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 20

Brief 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 urothelial cancer.

Conditions

Carcinoma, Transitional Cell

Keywords

urothelium; transitional; carcinoma; cancer; metastatic; tract

Outcome Measures

Primary Outcomes (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.

  1 year

Study Arms (2)

Vinflunine

EXPERIMENTAL

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

Best suportive care

OTHER

Best suportive care

Other: Undefined (standard care)

Interventions

Vinflunine DRUG

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).

Also known as: Javlor

Vinflunine

Undefined (standard care) OTHER

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

Also known as: undefined

Best suportive care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Spanish Oncology Genito-Urinary Group: lead

Study Sites (20)

Hospital General de Elda Virgen de la Salud

Elda, Alicante, 03600, Spain

Location

ICO-Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

ICO-Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Hospital Fundació Althaia

Manresa, Barcelona, 08243, Spain

Location

Corporació Sanitaria Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Complejo Hosp. Univ. de Santiago de Compostela

Santiago de Compostela, Galicia, 15706, Spain

Location

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

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

Barcelona, 08003, Spain

Location

H. Universitari Vall d'Hebrón

Barcelona, 08035, Spain

Location

Hospital Clínic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

H. General Universitario de Ciudad Real

Ciudad Real, 13005, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitari Son Espases

Palma de Mallorca, 07010, Spain

Location

Clínica Universitaria de Navarra (CUN)

Pamplona, 31002, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, 31008, Spain

Location

H. Universitario Virgen de la Macarena

Seville, 41009, Spain

Location

H. Universitario Virgen del Rocío

Seville, 41013, Spain

Location

IVO

Valencia, 46009, Spain

Location

Related Publications (1)

• 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.

  PMID: 28389316 DERIVED

Related Links

• Sponsor´s web-site

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Carcinoma; Neoplasms; Neoplasm Metastasis

Interventions

vinflunine; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2012
• First Posted: February 8, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: December 1, 2014
• Last Updated: April 4, 2019

Record last verified: 2012-02

Locations

ES (20)